R.K. MANUFACTURING CORPORATION OF CONNECTICUT

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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

Suture, Nonabsorbable, Synthetic, Polyamide (GAR) (4) Tampon, Menstrual, Unscented (HEB) (1)

Premarket Exempt

Clear

epic edge - 00855019008000 Catalog Number :

Device Description : 10/0 BL Mono Nylon, 10 cm length, 1/2 cir Spatula Ndl, Single Arm (single device)

Device Class :

Duns Number: 116162108

Premarket Exempt : No

Product Code : GAR

Prescription Use : Yes

Device Count : 1

epic edge - 00855019008017 Catalog Number :

Device Description : 10/0 BL Mono Nylon, 10 cm length, 3/8 cir Spatula Ndl, Single Arm (single device)

Device Class :

Duns Number: 116162108

Premarket Exempt : No

Product Code : GAR

Prescription Use : Yes

Device Count : 1

epic edge - 00855019008024 Catalog Number :

Device Description : 10/0 BL Mono Nylon, 30 cm length, 1/2 cir Spatula Ndl, Double Arm (single device)

Device Class :

Duns Number: 116162108

Premarket Exempt : No

Product Code : GAR

Prescription Use : Yes

Device Count : 1

epic edge - 00855019008031 Catalog Number :

Device Description : 10/0 BL Mono Nylon, 30 cm length, 3/8 cir Spatula Ndl, Double Arm (single device)

Device Class :

Duns Number: 116162108

Premarket Exempt : No

Product Code : GAR

Prescription Use : Yes

Device Count : 1

re.t.a - 00855019008093 Catalog Number :

Device Description : Reusable Tampon Applicator

Device Class : 2

Duns Number: 116162108

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 1

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