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Container, Frozen Donor Tissue Storage

Biowy Corporation

The following data is part of a premarket notification filed by Biowy Corporation with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK170150
510k NumberBK170150
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationContainer, Frozen Donor Tissue Storage
Applicant Biowy Corporation 27031 Vista Terrace Lake Forest,  CA  92630 US
Product CodeLPZ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-12
Decision Date2018-05-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851739007255 BK170150 0
00851739007248 BK170150 0
00851739007019 BK170150 0
00851739007002 BK170150 0

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