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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name container, frozen donor tissue storage
510(k) Number BK261343
Tradename Biowy Multi-Chamber Freezing Bag Set
Device Name Container, Frozen Donor Tissue Storage
Original Applicant
Biowy Corporation
27031 vista terrace
lake forest,  CA  92630
Classification Product Code
LPZ  
Date Received03/30/2026
Decision Date 04/29/2026
Decision substantially equivalent (SE)
Review Advisory Committee General Hospital
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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