Device, Warming, Blood And Plasma

Device, Warming. Blood And Plasma

Shotwell & Carr, Inc.

The following data is part of a premarket notification filed by Shotwell & Carr, Inc. with the FDA for Device, Warming, Blood And Plasma.

Pre-market Notification Details

Device IDBK990018
510k NumberBK990018
Device Name:Device, Warming, Blood And Plasma
ClassificationDevice, Warming. Blood And Plasma
Applicant Shotwell & Carr, Inc. 3535 Firewheel Drive suite A Flower Mound,  TX  75028 2628
Product CodeKZL  
CFR Regulation Number864.9205 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-08
Decision Date1999-10-13

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