McKeon Products, Inc.

Address:25460 GUENTHER,WARREN,MI,48091,US

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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

Dilator, Nasal (LWF) (5) Mouthguard, Over-The-Counter (OBR) (1)

Premarket Exempt

No Yes

Clear

LunaGuard - 00033732010306 Catalog Number : 1030

Device Class : U

Duns Number: 006522122

Premarket Exempt : No

Product Code : OBR

Prescription Use : No

Device Count : 1

Airmax - 00033732023016 Catalog Number : 2301

Device Class : 1

Duns Number: 006522122

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 1

Airmax - 00033732023023 Catalog Number : 2302

Device Class : 1

Duns Number: 006522122

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 1

Airmax - 00033732023252 Catalog Number : 2525

Device Class : 1

Duns Number: 006522122

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 1

Airmax - 00033732023498 Catalog Number : 2349

Device Class : 1

Duns Number: 006522122

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 1

Airmax - 00033732023504 Catalog Number : 2350

Device Class : 1

Duns Number: 006522122

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 1

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