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510(k) K203835

MIS Solution by Next Science, LLC — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2021
Date Received
December 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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  • K150792 — Next Science Wound Gel (December 17, 2015)

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