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510(k) K200413

Symphony by Aroa Biosurgery , Ltd. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2020
Date Received
February 19, 2020
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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