Siesta Medical

Address:101 Church St,Los Gatos,CA,95030,US

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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

Passer (HWQ) (1) Prelude Tongue Suspension System (ORY) (1) Wrench (HXC) (1)

Premarket Exempt

No Yes

Clear

Encore System - 00862211000206 Catalog Number :

Device Description : Implants and delivery tools for hyoid and tongue suspension.

Device Class : 2

Duns Number: 940968808

Premarket Exempt : No

Product Code : ORY

Prescription Use : No

Device Count : 1

Revolution - 00862211000213 Catalog Number :

Device Class : 1

Duns Number: 940968808

Premarket Exempt : Yes

Product Code : HWQ

Prescription Use : Yes

Device Count : 1

Encore Revision Kit - 00862211000220 Catalog Number :

Device Class : 1

Duns Number: 940968808

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : No

Device Count : 1

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