System, Processing For Frozen Blood

System, Processing For Frozen Blood

Cryosan Inc.

The following data is part of a premarket notification filed by Cryosan Inc. with the FDA for System, Processing For Frozen Blood.

Pre-market Notification Details

Device IDBK820018
510k NumberBK820018
Device Name:System, Processing For Frozen Blood
ClassificationSystem, Processing For Frozen Blood
Applicant Cryosan Inc. 850 Providence Highway Dedham,  MA  02026
Product CodeKSW  
CFR Regulation Number864.9145 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-11-15
Decision Date1982-12-16

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