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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 K213652
Device Name Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)
Applicant
Cresilon, Inc.
87 35th Street, Suite 603/604
Brooklyn,  NY  11232
Applicant Contact Hassaan W. Ahmad
Correspondent
Cresilon, Inc.
87 35th Street, Suite 603/604
Brooklyn,  NY  11232
Correspondent Contact Hassaan W. Ahmad
Classification Product Code
FRO  
Date Received11/19/2021
Decision Date 06/28/2023
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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