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510(k) K160136

Flowable Wound Matrix by Cook Biotech Incorporated — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2016
Date Received
January 20, 2016
Clearance Type
Traditional
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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