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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 K932899
Device Name CLASSIQUE
Original Applicant
HEMISPHERES MARKETING CO. LTD.
6501 n.w. 36th street, #101
miami,  FL  33166
Original Contact lewis
Regulation Number878.3800
Classification Product Code
KCZ  
Date Received06/14/1993
Decision Date 12/16/1993
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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