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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 K933465
Device Name COSMET
Applicant
Great Bay Medical Products, Inc.
750 Central Ave., Suite H
Dover,  NH  03820
Applicant Contact MELVIN E PROSTKOFF
Correspondent
Great Bay Medical Products, Inc.
750 Central Ave., Suite H
Dover,  NH  03820
Correspondent Contact MELVIN E PROSTKOFF
Regulation Number878.3800
Classification Product Code
KCZ  
Date Received07/16/1993
Decision Date 07/20/1994
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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