MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11

Set, I.v. Fluid Transfer

CRITICAL DEVICE CORP.

The following data is part of a premarket notification filed by Critical Device Corp. with the FDA for Macrobore Tubing - Cdc-f-1 Through Cdc-f-11.

Pre-market Notification Details

Device IDK955896
510k NumberK955896
Device Name:MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11
ClassificationSet, I.v. Fluid Transfer
Applicant CRITICAL DEVICE CORP. 499 NIBUS ST. Brea,  CA  92621
ContactSusan D Goldsetin-falk
CorrespondentSusan D Goldsetin-falk
CRITICAL DEVICE CORP. 499 NIBUS ST. Brea,  CA  92621
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-29
Decision Date1996-02-06

NIH GUDID Devices

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