IMPLANTECH NASAL LABIAL IMPLANT— 510(k) K943988

Name: FDA 510(k) clearance K943988
Creator: U.S. Food and Drug Administration
Published: 1995-01-27

Substantially Equivalent

Implantech Associates, Inc.

FDA 510(k) clearance K943988 for IMPLANTECH NASAL LABIAL IMPLANT, Substantially Equivalent on 1995-01-27. Applicant: Implantech Associates, Inc.. Device class: 2.

Clearance details

Applicant: Implantech Associates, Inc.
Product code: Code LZK
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 1994-08-16
Decision date: 1995-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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