IRRIGATION ACCESS CAP

Set, Administration, Intravascular

MCGAW, INC.

The following data is part of a premarket notification filed by Mcgaw, Inc. with the FDA for Irrigation Access Cap.

Pre-market Notification Details

Device IDK932856
510k NumberK932856
Device Name:IRRIGATION ACCESS CAP
ClassificationSet, Administration, Intravascular
Applicant MCGAW, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine,  CA  92713 -9791
ContactJohn D'angelo
CorrespondentJohn D'angelo
MCGAW, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine,  CA  92713 -9791
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-10
Decision Date1994-01-26

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