CLAVE STOPCOCK

Stopcock, I.v. Set

ICU MEDICAL, INC

The following data is part of a premarket notification filed by Icu Medical, Inc with the FDA for Clave Stopcock.

Pre-market Notification Details

Device IDK080077
510k NumberK080077
Device Name:CLAVE STOPCOCK
ClassificationStopcock, I.v. Set
Applicant ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City,  UT  84123
ContactTracy Best
CorrespondentTracy Best
ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City,  UT  84123
Product CodeFMG  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-11
Decision Date2008-02-13
Summary:summary

NIH GUDID Devices

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