Lac-Mac Limited

Address:847 HIGHBURY AVE,LONDON Ontario,CA

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Gown, Surgical (FYA) (10)

Premarket Exempt

No Yes

Clear

Lac-Mac - 00627755051011 Catalog Number : 005XE-XS

Device Description : Surgical Gown, Level 4, with ties, knit neckband, set-in sleeve, patented Size XS

Device Class : 2

Duns Number: 201276334

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Lac-Mac - 00627755051028 Catalog Number : 005XEAA-XS

Device Description : Surgical Gown, Level 3, with ties, knit neckband, set-in sleeve, patented Size XS

Device Class : 2

Duns Number: 201276334

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Lac-Mac - 00627755051035 Catalog Number : 005XEAB-XS

Device Description : Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size XS

Device Class : 2

Duns Number: 201276334

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Lac-Mac - 00627755051042 Catalog Number : 005XEAE-XS

Device Description : Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patente Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size XS

Device Class : 2

Duns Number: 201276334

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Lac-Mac - 00627755051097 Catalog Number : 005XEAK-XS

Device Description : Surgical Gown, Level 3, color coded patch right back hem, patented Size XS

Device Class : 2

Duns Number: 201276334

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Lac-Mac - 00627755051127 Catalog Number : 005XFAB-XS

Device Description : Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at w Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size XS

Device Class : 2

Duns Number: 201276334

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Lac-Mac - 00627755051134 Catalog Number : 005XFAE-XS

Device Description : Surgical Gown, Level 3, tie closure, knit neckband, raglan sleeves, patented Siz Surgical Gown, Level 3, tie closure, knit neckband, raglan sleeves, patented Size XS

Device Class : 2

Duns Number: 201276334

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Lac-Mac - 00627755051158 Catalog Number : 005XH-XS

Device Description : Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size XS

Device Class : 2

Duns Number: 201276334

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Lac-Mac - 00627755051189 Catalog Number : 005XX-XS

Device Description : Surgical Gown, Level 4, with tie closure Size XS

Device Class : 2

Duns Number: 201276334

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Lac-Mac - 00627755051646 Catalog Number : 005XEAC-XS

Device Description : Surgical Gown, Level 4, gripper closure, knit neckband, set-in sleeves, patented Size XS

Device Class : 2

Duns Number: 201276334

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

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