ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN— 510(k) K111179

Name: FDA 510(k) clearance K111179
Creator: U.S. Food and Drug Administration
Published: 2011-07-01

Substantially Equivalent

Siesta Medical, Inc.

FDA 510(k) clearance K111179 for ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN, Substantially Equivalent on 2011-07-01. Applicant: Siesta Medical, Inc.. Device class: 2.

Clearance details

Applicant: Siesta Medical, Inc.
Product code: Code ORY
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2011-04-27
Decision date: 2011-07-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Los Gatos, CA, US

Download summary PDF View on FDA.gov ↗

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