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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K253204
Device Name Catalyze
Applicant
BioTissue Holdings, Inc.
7300 Corporate Center Dr., Suite 700
Miami,  FL  33126
Applicant Contact Lorraine Chua
Correspondent
BioTissue Holdings, Inc.
7300 Corporate Center Dr., Suite 700
Miami,  FL  33126
Correspondent Contact Lorraine Chua
Classification Product Code
KGN  
Date Received09/26/2025
Decision Date 06/05/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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