MEDELA THOPAZ

Pump, Portable, Aspiration (manual Or Powered)

MEDELA AG

The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Thopaz.

Pre-market Notification Details

Device IDK130210
510k NumberK130210
Device Name:MEDELA THOPAZ
ClassificationPump, Portable, Aspiration (manual Or Powered)
Applicant MEDELA AG LAETTICHSTRASSE 4B Baar, Zug,  CH Ch-6341
ContactMarkus Buetler
CorrespondentMarkus Buetler
MEDELA AG LAETTICHSTRASSE 4B Baar, Zug,  CH Ch-6341
Product CodeBTA  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-29
Decision Date2013-03-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07612367038560 K130210 000
07612367017497 K130210 000
07612367017480 K130210 000
07612367014205 K130210 000

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