IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING— 510(k) K964846

Name: FDA 510(k) clearance K964846
Creator: U.S. Food and Drug Administration
Published: 1997-02-12

Substantially Equivalent

Implantech Associates, Inc.

FDA 510(k) clearance K964846 for IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING, Substantially Equivalent on 1997-02-12. Applicant: Implantech Associates, Inc.. Device class: 1.

Clearance details

Applicant: Implantech Associates, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1996-12-03
Decision date: 1997-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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