VENTED MILLEX -GV, CATHIVEX -GV

Filter, Conduction, Anesthetic

MERCK MILLIPORE LTD.

The following data is part of a premarket notification filed by Merck Millipore Ltd. with the FDA for Vented Millex -gv, Cathivex -gv.

Pre-market Notification Details

Device IDK133004
510k NumberK133004
Device Name:VENTED MILLEX -GV, CATHIVEX -GV
ClassificationFilter, Conduction, Anesthetic
Applicant MERCK MILLIPORE LTD. 28820 SINGLE OAK DRIVE Temecula,  CA  92590
ContactCindy Penny
CorrespondentCindy Penny
MERCK MILLIPORE LTD. 28820 SINGLE OAK DRIVE Temecula,  CA  92590
Product CodeBSN  
CFR Regulation Number868.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-25
Decision Date2014-03-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04054839076619 K133004 000

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