Processing Systems For Frozen Blood

System, Processing For Frozen Blood

Cobe Laboratories, Inc.

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

Pre-market Notification Details

Device IDBK840008
510k NumberBK840008
Device Name:Processing Systems For Frozen Blood
ClassificationSystem, Processing For Frozen Blood
Applicant Cobe Laboratories, Inc. 1185 Oak Street Lakewood,  CO  80215
Product CodeKSW  
CFR Regulation Number864.9145 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-19
Decision Date1984-06-08

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