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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 K083133
Device Name SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS
Applicant
Andover Healthcare, Inc.
9 Fanaras Dr.
Salisbury,  MA  01952
Applicant Contact VALERIE GUNN
Correspondent
Andover Healthcare, Inc.
9 Fanaras Dr.
Salisbury,  MA  01952
Correspondent Contact VALERIE GUNN
Classification Product Code
FRO  
Date Received10/23/2008
Decision Date 10/30/2009
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
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