PRIMARY IV SET

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 Primary Iv Set.

Pre-market Notification Details

Device IDK964435
510k NumberK964435
Device Name:PRIMARY IV SET
ClassificationStopcock, I.v. Set
Applicant ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente,  CA  92673
ContactRichard Waters
CorrespondentRichard Waters
ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente,  CA  92673
Product CodeFMG  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-05
Decision Date1997-04-02
Summary:summary

NIH GUDID Devices

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