Insufflator 50L FM134

Insufflator, Laparoscopic

W.O.M WORLD OF MEDICINE GMBH

The following data is part of a premarket notification filed by W.o.m World Of Medicine Gmbh with the FDA for Insufflator 50l Fm134.

Pre-market Notification Details

Device IDK153513
510k NumberK153513
Device Name:Insufflator 50L FM134
ClassificationInsufflator, Laparoscopic
Applicant W.O.M WORLD OF MEDICINE GMBH SALZUFER 8 Berlin,  DE 10587
ContactSoeren Markworth
CorrespondentSusanne Raab
Susanne Raab 1480 Cambridge Street Cambridge,  MA  02139
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-07
Decision Date2016-03-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056702005771 K153513 000
04056702008802 K153513 000
04056702008895 K153513 000
04056702007218 K153513 000
04056702007379 K153513 000
04056702007430 K153513 000
04056702000721 K153513 000
04056702002602 K153513 000
04056702002633 K153513 000
04056702002824 K153513 000
04056702002831 K153513 000
04056702003227 K153513 000
04056702008789 K153513 000

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