FDA.report

510(k) K250115

Device
Hemastyl(™) Wound Dressing
Applicant
Rapid Nexus Nanotech Wound Solutions, Inc.
510(k) number
K250115
Product code
FRO
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-14
Date received
2025-01-16
Classification name
Dressing, Wound, Drug
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Margaret Kalmeta
Address
830 Challenger St., Suite 360 Brea CA US 92821 92821

FDA Registration Numbers

Source Documents

510(k) summary PDF

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