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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K962421
Device Name SORBCEL ALGINATE/CMC WOUND DRESSING
Applicant
INNOVATIVE TECHNOLOGIES LTD.
ROAD THREE, WINSFORD
INDUSTRIAL ESTATE
WINSFORD, CHESHIRE,  GB CW7 3PD
Applicant Contact PRISCILLA WHITEHEAD
Correspondent
INNOVATIVE TECHNOLOGIES LTD.
ROAD THREE, WINSFORD
INDUSTRIAL ESTATE
WINSFORD, CHESHIRE,  GB CW7 3PD
Correspondent Contact PRISCILLA WHITEHEAD
Regulation Number880.5090
Classification Product Code
KMF  
Date Received06/24/1996
Decision Date 07/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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