Blood And Plasma Warming Devices

Device, Warming. Blood And Plasma

Ackrad Laboratories

The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Blood And Plasma Warming Devices.

Pre-market Notification Details

Device IDBK890018
510k NumberBK890018
Device Name:Blood And Plasma Warming Devices
ClassificationDevice, Warming. Blood And Plasma
Applicant Ackrad Laboratories 70 Jackson Dr. Cranford,  NJ  07016
Product CodeKZL  
CFR Regulation Number864.9205 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-22
Decision Date1990-09-21

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