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, Jaw Repositioning (LQZ) (10)

Premarket Exempt

Clear

SML - D85463725S1 Catalog Number :

Device Description : LAMBERG SLEEP WELL DEVICE

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463750S1 Catalog Number :

Device Description : GREENBURG SNORE-NO-MORE

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463760AS1 Catalog Number :

Device Description : ZYPPAH A

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463760HLS1 Catalog Number :

Device Description : ZYPPAH HL

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463760KS1 Catalog Number :

Device Description : ZYPPAH-K

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463760S1 Catalog Number :

Device Description : ZYPPAH-V

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463760TES1 Catalog Number :

Device Description : ZYPPAH T

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463760TS1 Catalog Number :

Device Description : ZYPPAH V W/ THERMACRYL

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463760VHS1 Catalog Number :

Device Description : ZYPPAH VH

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85466030S1 Catalog Number :

Device Description : ADD C.P.A.P-PRO

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

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