MEDELA THOPAZ, MODEL 200 0288

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, Model 200 0288.

Pre-market Notification Details

Device IDK080212
510k NumberK080212
Device Name:MEDELA THOPAZ, MODEL 200 0288
ClassificationPump, Portable, Aspiration (manual Or Powered)
Applicant MEDELA AG LAETTICHSTRASSE 4B Baar, Zug,  CH Ch-6341
ContactBruno Gretler
CorrespondentBruno Gretler
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 Received2008-01-29
Decision Date2008-07-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.