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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 K071371
FOIA Releasable 510(k) K071371
Device Name COPA AMD ANTIMICROBIAL WOUND DRESSING
Applicant
Tyco Healthcare Group LP
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact JAMES WALSH
Correspondent
Tyco Healthcare Group LP
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact JAMES WALSH
Classification Product Code
FRO  
Date Received05/16/2007
Decision Date 11/19/2007
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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