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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K152033
Device Name Cook ECM Powder
Applicant
Cook Biotech Incorporated
1425 Innovation Pl.
West Lafayette,  IN  47906
Applicant Contact Perry W Guinn
Correspondent
Cook Biotech Incorporated
1425 Innovation Pl.
West Lafayette,  IN  47906
Correspondent Contact Katie Molland
Classification Product Code
KGN  
Date Received07/22/2015
Decision Date 08/19/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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