MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR

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 Dominant 35 C/i Secretion And Surgical Aspirator.

Pre-market Notification Details

Device IDK043544
510k NumberK043544
Device Name:MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR
ClassificationPump, Portable, Aspiration (manual Or Powered)
Applicant MEDELA AG LAETTICHSTRASSE 7 Baar, Zug,  CH 6341
ContactWerner Frei
CorrespondentStefan Preiss
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeBTA  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-12-23
Decision Date2005-01-07
Summary:summary

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