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) (8) Device, Jaw Repositioning (LQZ) (2)

Premarket Exempt

Clear

SML - D85463603ALCS1 Catalog Number :

Device Description : FULL BREATH LOWER ACRYLIC W/ CLASPS

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463603AO2S1 Catalog Number :

Device Description : FULL BREATH-THERMAL W/02 TUBES

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463603AS1 Catalog Number :

Device Description : FULL BREATH UPPER THERMAL ACRYLIC

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463603L1 Catalog Number :

Device Description : FULL BREATH LOWER-THERMAL ACY W/ PTR

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463603LS1 Catalog Number :

Device Description : FULL BREATH LOWER-THERMAL ACY W/ PTR

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463603NS1 Catalog Number :

Device Description : FULL BREATH-NO SNORE / ACRYLIC

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463603PMTS1 Catalog Number :

Device Description : FULL BREATH-UPPER/PMT BASE

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463603WS1 Catalog Number :

Device Description : FULL BREATH-ADJ. PTR / ACRYLIC

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

SML - D85463725AS1 Catalog Number :

Device Description : LAMBERG SLEEP WELL- ACRYLIC

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463725PMTS1 Catalog Number :

Device Description : LAMBERG SLEEP WELL-PMT BASE

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

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