PHOENIX ETE TISSUE EXTENSION SYSTEM— 510(k) K962144

Name: FDA 510(k) clearance K962144
Creator: U.S. Food and Drug Administration
Published: 1997-01-14

Substantially Equivalent

Phoenix Biomedical Corp.

FDA 510(k) clearance K962144 for PHOENIX ETE TISSUE EXTENSION SYSTEM, Substantially Equivalent on 1997-01-14. Applicant: Phoenix Biomedical Corp.. Device class: 1.

Clearance details

Applicant: Phoenix Biomedical Corp.
Product code: Code MKY
Device class: Class 1
Regulation: 21 CFR 878.4320
Advisory panel: General, Plastic Surgery
Date received: 1996-06-03
Decision date: 1997-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norristown, PA, US

Download summary PDF View on FDA.gov ↗

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