Device, Heat Sealing

Device, Heat-sealing

Gambro Inc.

The following data is part of a premarket notification filed by Gambro Inc. with the FDA for Device, Heat Sealing.

Pre-market Notification Details

Device IDBK870024
510k NumberBK870024
Device Name:Device, Heat Sealing
ClassificationDevice, Heat-sealing
Applicant Gambro Inc. 23872 Kelsey Road Barrington,  IL  60010
Product CodeKSD  
CFR Regulation Number864.9750 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-02
Decision Date1987-11-02

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