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510(k) K150792

Next Science Wound Gel by Next Science, LLC — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2015
Date Received
March 25, 2015
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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  • K163188 — Next Science Wound Gel (Rx) (March 6, 2017)
  • K161165 — Next Science Irrigation Solution (September 7, 2016)

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