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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 K970439
Device Name PROXIDERM (D-460,D 90 460,D 180,460, PS 460)
Applicant
Progressive Surgical Products, Inc.
694 Main St.
Westbury,  NY  11590
Applicant Contact ROBERT ODDSON
Correspondent
Progressive Surgical Products, Inc.
694 Main St.
Westbury,  NY  11590
Correspondent Contact ROBERT ODDSON
Regulation Number878.4320
Classification Product Code
MKY  
Date Received02/05/1997
Decision Date 04/16/1997
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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