MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR

Set, Administration, Intravascular

MEDEGEN MEDICAL MANUFACTURING SERVICES, INC.

The following data is part of a premarket notification filed by Medegen Medical Manufacturing Services, Inc. with the FDA for Modification To The Nac Plus Needleless Access Connector.

Pre-market Notification Details

Device IDK041179
510k NumberK041179
Device Name:MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR
ClassificationSet, Administration, Intravascular
Applicant MEDEGEN MEDICAL MANUFACTURING SERVICES, INC. 930 WANAMAKER Ontario,  CA  91761 -8151
ContactTim Truitt
CorrespondentTim Truitt
MEDEGEN MEDICAL MANUFACTURING SERVICES, INC. 930 WANAMAKER Ontario,  CA  91761 -8151
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-06
Decision Date2004-06-04

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