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510(k) K951324

MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS by Maxol Limited L.C. — Product Code KCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1995
Date Received
March 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Breast, External, Used With Adhesive
Device Class
Class I
Regulation Number
878.3800
Review Panel
SU
Submission Type

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