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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K251757
Device Name Puracyn® Plus Antimicrobial Irrigation Solution
Applicant
Innovacyn, Inc.
3546 N. Riverside Ave.
Rialto,  CA  92377
Applicant Contact Hungnan Lo
Correspondent
Innovacyn, Inc.
3546 N. Riverside Ave.
Rialto,  CA  92377
Correspondent Contact Hungnan Lo
Classification Product Code
FRO  
Subsequent Product Code
FQH  
Date Received06/09/2025
Decision Date 01/05/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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