FDA 510(k)

MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS

K-Number: K951324 · 1995-05-26

Decision Date1995-05-26

Product CodeKCZ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Maxol Limited L.C.. It received FDA 510(k) clearance on 1995-05-26 under 510(k) number K951324. The device is classified under product code KCZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS?

MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS is a medical device that received FDA 510(k) clearance on 1995-05-26. The listed applicant is Maxol Limited L.C.. The 510(k) number is K951324.

When did MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS receive FDA 510(k) clearance?

MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS received FDA 510(k) clearance on 1995-05-26, under 510(k) number K951324.

Who is the listed applicant for MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS?

The FDA 510(k) record lists Maxol Limited L.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS?

The FDA product code for MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS is KCZ.

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Official Source

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