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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 K071552
Device Name PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
Applicant
Medline Industries, Inc.
One Medline Place
Mundelein,  IL  60060
Applicant Contact MATT CLAUSEN
Correspondent
Medline Industries, Inc.
One Medline Place
Mundelein,  IL  60060
Correspondent Contact MATT CLAUSEN
Classification Product Code
FRO  
Date Received06/06/2007
Decision Date 04/25/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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