POSITIVE PRESSURE CONNECTOR

Set, Administration, Intravascular

ICU MEDICAL, INC.

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

Pre-market Notification Details

Device IDK973167
510k NumberK973167
Device Name:POSITIVE PRESSURE CONNECTOR
ClassificationSet, Administration, Intravascular
Applicant ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente,  CA  92673
ContactSalvadore F Palomares
CorrespondentSalvadore F Palomares
ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente,  CA  92673
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-25
Decision Date1997-11-17
Summary:summary

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