Cleared Traditional

K150792 - Next Science Wound Gel (FDA 510(k) Clearance)

Dec 2015
Decision
267d
Days
-
Risk

K150792 is an FDA 510(k) clearance for the Next Science Wound Gel. This device is classified as a Dressing, Wound, Drug.

Submitted by Next Science, LLC (Jacksonville, US). The FDA issued a Cleared decision on December 17, 2015, 267 days after receiving the submission on March 25, 2015.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K150792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2015
Decision Date December 17, 2015
Days to Decision 267 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO - Dressing, Wound, Drug
Device Class -

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