MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS— 510(k) K951324

Name: FDA 510(k) clearance K951324
Creator: U.S. Food and Drug Administration
Published: 1995-05-26

Substantially Equivalent

Maxol Limited L.C.

FDA 510(k) clearance K951324 for MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS, Substantially Equivalent on 1995-05-26. Applicant: Maxol Limited L.C.. Device class: 1.

Clearance details

Applicant: Maxol Limited L.C.
Product code: Code KCZ
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1995-03-23
Decision date: 1995-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Overland Park, KS, US

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