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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 K071442
Device Name SUPRASORB A +AG
Applicant
Specialty Fibres and Materials, Ltd.
101, Lockhurst Ln.
Coventry,  GB CV6 5RS
Applicant Contact COLIN LUDFORD
Correspondent
Specialty Fibres and Materials, Ltd.
101, Lockhurst Ln.
Coventry,  GB CV6 5RS
Correspondent Contact COLIN LUDFORD
Classification Product Code
FRO  
Date Received05/23/2007
Decision Date 05/01/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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