HARD TISSUE REPLACEMENT (HTR) GRANULAR— 510(k) K934861

Name: FDA 510(k) clearance K934861
Creator: U.S. Food and Drug Administration
Published: 1994-11-04

Substantially Equivalent

Poly-Medics,Inc.

FDA 510(k) clearance K934861 for HARD TISSUE REPLACEMENT (HTR) GRANULAR, Substantially Equivalent on 1994-11-04. Applicant: Poly-Medics,Inc.. Device class: 2.

Clearance details

Applicant: Poly-Medics,Inc.
Product code: Code KKY
Device class: Class 2
Regulation: 21 CFR 878.3500
Advisory panel: General, Plastic Surgery
Date received: 1993-10-12
Decision date: 1994-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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