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510(k) K171231

Endoform Topical Matrix by Aroa Biosurgery — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2017
Date Received
April 27, 2017
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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