SELANE PRODUCTS, INC.

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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

Clear

SML - D85463316ES1 Catalog Number :

Device Description : TAP 3 ELITE

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463316GS1 Catalog Number :

Device Description : TAP 3 GREENBURG STYLE

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463316S1 Catalog Number :

Device Description : TAP 3

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463320S1 Catalog Number :

Device Description : E.M.A.

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463400S1 Catalog Number :

Device Description : OASYS-DUAL LAMINATE

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463400TS1 Catalog Number :

Device Description : OASYS THERMAL ACRYLIC

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463603AACS1 Catalog Number :

Device Description : FULL BREATH-UPPER ACRYLIC W/CLASPS

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463603AAO2S1 Catalog Number :

Device Description : FBS-ACRYLIC W/02 TUBES - NO CLASPS

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463603AAS1 Catalog Number :

Device Description : FULL BREATH-ALL ACRYLIC

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463603ACO2S1 Catalog Number :

Device Description : FULL BREATH--W/02 TUBES AND BALL CLASPS

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

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