3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP— 510(k) K141027

Name: FDA 510(k) clearance K141027
Creator: U.S. Food and Drug Administration
Published: 2014-07-10

Substantially Equivalent

Implantech Associates, Inc.

FDA 510(k) clearance K141027 for 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP, Substantially Equivalent on 2014-07-10. Applicant: Implantech Associates, Inc.. Device class: 2.

Clearance details

Applicant: Implantech Associates, Inc.
Product code: Code FWP
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 2014-04-22
Decision date: 2014-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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