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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Breast, External, Used With Adhesive
510(k) Number K951324
Device Name MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS
Applicant
Maxol Limited L.C.
10006 W. 97 Ter.
Overland Park,  KS  66212
Applicant Contact MARK SCHANZE
Correspondent
Maxol Limited L.C.
10006 W. 97 Ter.
Overland Park,  KS  66212
Correspondent Contact MARK SCHANZE
Regulation Number878.3800
Classification Product Code
KCZ  
Date Received03/23/1995
Decision Date 05/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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