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) (9) Device, Jaw Repositioning (LQZ) (1)

Premarket Exempt

Clear

SML - D85463260S1 Catalog Number :

Device Description : SILENT NIGHT APPLIANCE

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463270S1 Catalog Number :

Device Description : THERMOFORMED M.R.A.

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463280AS1 Catalog Number :

Device Description : Z QUIET ACRYLIC W/ CLASPS

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463280S1 Catalog Number :

Device Description : Z-QUIET PRO

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463300S1 Catalog Number :

Device Description : TAP APPLIANCE

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463310S1 Catalog Number :

Device Description : TAP/ACRYLIC & CLASPS

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463312S1 Catalog Number :

Device Description : TAP/TALON

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463313S1 Catalog Number :

Device Description : TAP-TL

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463316AS1 Catalog Number :

Device Description : TAP 3 W/ ACRYLIC & BALL CLASPS

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463316EAS1 Catalog Number :

Device Description : TAP 3 ELITE ACRYLIC W/ CLASPS

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

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