Empty Containers For The Collection & Processing Of Blood/Blood Components

Container, Empty, For Collection & Processing Of Blood & Blood Components

Utah Medical Products, Inc.

The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.

Pre-market Notification Details

Device IDBK970026
510k NumberBK970026
Device Name:Empty Containers For The Collection & Processing Of Blood/Blood Components
ClassificationContainer, Empty, For Collection & Processing Of Blood & Blood Components
Applicant Utah Medical Products, Inc. 7043 South 300 West Midvale,  UT  84047 US
Product CodeKSR  
CFR Regulation Number864.9100 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-28
Decision Date1998-01-28

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