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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
Applicant
Hemispheres Marketing Co. , Ltd.
6501 NW 36th St., #101
Miami,  FL  33166
Applicant Contact LEWIS
Correspondent
Hemispheres Marketing Co. , Ltd.
6501 NW 36th St., #101
Miami,  FL  33166
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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