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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 K911247
Device Name YOURS TRULY ASYMMETRICAL BREAST FORM
Applicant
JOBST INSTITUTE, INC.
BOX 653
TOLEDO,  OH  43694
Applicant Contact BRUCE W WETZEL
Correspondent
JOBST INSTITUTE, INC.
BOX 653
TOLEDO,  OH  43694
Correspondent Contact BRUCE W WETZEL
Regulation Number878.3800
Classification Product Code
KCZ  
Date Received03/21/1991
Decision Date 03/29/1991
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
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