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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, frozen donor tissue storage
510(k) Number BK170150
Tradenames Biowy Freezing Bag FB1000, Biowy Freezing Bag FB250, Biowy Freezing Bag FB50, Biowy Freezing Bag FB500
Device Name Container, Frozen Donor Tissue Storage
Original Applicant
Biowy Corporation
27031 vista terrace
lake forest,  CA  92630
Classification Product Code
LPZ  
Date Received12/12/2017
Decision Date 05/11/2018
Decision substantially equivalent (SE)
Review Advisory Committee General Hospital
Type 510(k) Traditional
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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