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Parker Quality & Compliance

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510(k) clearance

SkinSmart Antimicrobial HydroGel

FDA 510(k) source

510(k) number
K254041
Applicant
Magic Science Supply, LLC
Decision date
Sep 11, 2026
Date received
Dec 16, 2025
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
FRO
Device type
Dressing, Wound, Drug
Device class
Unclassified
Advisory committee
Unknown
Statement or summary
Summary
Third party
N
Location
Edina, MN, US