SOMNOMED, INC.

SOMNOMED, INC.

Address:6513 Windcrest Dr Ste 100,Plano,TX,75024,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

Device, Anti-Snoring (LRK) (10)

Premarket Exempt

No

Clear

SomnoDent Air - 00851826007007 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

SomnoDent Air+ - 00851826007014 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Classic - 00851826007021 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Flex - 00851826007038 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Fusion Flex - 00851826007045 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Fusion Classic - 00851826007052 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Herbst Advance Flex - 00851826007069 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Herbst Telescopic Classic - 00851826007076 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

SUAD - 00851826007083 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

SUAD Ultra - 00851826007090 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

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