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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Occlusive
510(k) Number K964398
Device Name SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
Applicant
Polymedica Industries, Inc.
581 Conference Place
Golden,,  CO  80401
Applicant Contact JULIE CHAFFEE
Correspondent
Polymedica Industries, Inc.
581 Conference Place
Golden,,  CO  80401
Correspondent Contact JULIE CHAFFEE
Classification Product Code
MGP  
Date Received11/04/1996
Decision Date 10/24/1997
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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