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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 K982234
Device Name AL-GEN CALCIUM ALGINATE DRESSING
Applicant
INNOVATIVE TECHNOLOGIES LTD.
ROAD THREE, WINSFORD
INDUSTRIAL ESTATE
WINSFORD, CHESHIRE,  GB CW7 3PD
Applicant Contact CJ OAKES
Correspondent
INNOVATIVE TECHNOLOGIES LTD.
ROAD THREE, WINSFORD
INDUSTRIAL ESTATE
WINSFORD, CHESHIRE,  GB CW7 3PD
Correspondent Contact CJ OAKES
Regulation Number880.5090
Classification Product Code
KMF  
Date Received06/25/1998
Decision Date 09/08/1998
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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