SAFELINE SYSTEM TURN LOCK CANNULA

Set, Administration, Intravascular

MCGAW, INC.

The following data is part of a premarket notification filed by Mcgaw, Inc. with the FDA for Safeline System Turn Lock Cannula.

Pre-market Notification Details

Device IDK941244
510k NumberK941244
Device Name:SAFELINE SYSTEM TURN LOCK CANNULA
ClassificationSet, Administration, Intravascular
Applicant MCGAW, INC. 2525 MCGAW AVE. Irvine,  CA  92714 -5895
ContactJohn G D'angelo
CorrespondentJohn G D'angelo
MCGAW, INC. 2525 MCGAW AVE. Irvine,  CA  92714 -5895
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-15
Decision Date1994-11-29

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