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510(k) K250115

Hemastyl(™) Wound Dressing by Rapid Nexus Nanotech Wound Solutions, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2025
Date Received
January 16, 2025
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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