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510(k) K152033

Cook ECM Powder by Cook Biotech Incorporated — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2015
Date Received
July 22, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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