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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Skin Closure
510(k) Number K942425
Device Name PROXIDERM (TENTATIVE)
Applicant
Progressive Surgical Products, Inc.
694 Main St.
Westbury,  NY  11590
Applicant Contact ROBERT ODDSEN
Correspondent
Progressive Surgical Products, Inc.
694 Main St.
Westbury,  NY  11590
Correspondent Contact ROBERT ODDSEN
Regulation Number878.4320
Classification Product Code
MKY  
Date Received05/20/1994
Decision Date 11/04/1994
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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