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510(k) K223377

BIASURGE Advanced Surgical Solution by Rochal Technologies, LLC — Product Code FRO

K223377 is an FDA 510(k) premarket notification submitted by Rochal Technologies, LLC for the device "BIASURGE Advanced Surgical Solution". The FDA issued a decision of Substantially Equivalent on Mar 30, 2023. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 30, 2023
Date Received
Nov 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

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FDA data resources