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510(k) K163188

Next Science Wound Gel (Rx) by Next Science, LLC — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2017
Date Received
November 14, 2016
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

Other clearances by Next Science, LLC

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  • K203835 — MIS Solution (April 23, 2021)
  • K192349 — Bactisure Wound Lavage (January 23, 2020)
  • K161165 — Next Science Irrigation Solution (September 7, 2016)
  • K150792 — Next Science Wound Gel (December 17, 2015)

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