SELANE PRODUCTS, INC.

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) (5) Device, Jaw Repositioning (LQZ) (4) Mouthguard, Prescription (MQC) (1)

Premarket Exempt

No

Clear

SML - D85460994LS1 Catalog Number :

Device Description : MRNA-LOWER

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85460994S1 Catalog Number :

Device Description : MRNA-UPPER

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D854620651 Catalog Number :

Device Description : The POD

Device Class : U

Duns Number: 066642729

Premarket Exempt : No

Product Code : MQC

Prescription Use : No

Device Count : 1

SML - D85463120BS1 Catalog Number :

Device Description : T.R.D. W/ BREATHING HOLES

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463120S1 Catalog Number :

Device Description : T.R.D.

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463210S1 Catalog Number :

Device Description : SOFT PALATAL LIFT

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463220S1 Catalog Number :

Device Description : M.I.R.S.

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463221S1 Catalog Number :

Device Description : M.I.R.S.-TALON

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463224S1 Catalog Number :

Device Description : A.S.A. SLEEP APPLIANCE

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463225AHS1 Catalog Number :

Device Description : DORSAL ZYPPAH HYBRID

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

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