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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 K953781
Device Name INNOVATIVE TECHNOLOGIES CALCIUM ALGINATE WOUND DRESSINGS
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 Received08/14/1995
Decision Date 09/01/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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