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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.
Rd. Three
Winsford Industrial Estate
Winsford, Cheshire,  GB CW7 3PD
Applicant Contact PRISCILLA WHITEHEAD
Correspondent
Innovative Technologies , Ltd.
Rd. 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
Predetermined Change
Control Plan Authorized		 No
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