FDA.report

510(k) K251757

Device
Puracyn® Plus Antimicrobial Irrigation Solution
Applicant
Innovacyn, Inc.
510(k) number
K251757
Product code
FRO
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-05
Date received
2025-06-09
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
Hungnan Lo
Address
3546 N. Riverside Ave. Rialto CA US 92377 92377

FDA Registration Numbers

Source Documents

510(k) summary PDF

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