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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, Drug
510(k) Number K991287
Device Name SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
Applicant
Advanced Medical Solutions Group Plc
Rd. Three,
Winford Industrial Estate
Winsford, Cheshire,  GB CW7 3PD
Applicant Contact CHRISTOPHER OAKES
Correspondent
Advanced Medical Solutions Group Plc
Rd. Three,
Winford Industrial Estate
Winsford, Cheshire,  GB CW7 3PD
Correspondent Contact CHRISTOPHER OAKES
Classification Product Code
FRO  
Date Received04/14/1999
Decision Date 06/29/1999
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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