HYSTEROSCOPY PUMP HM6

Insufflator, Hysteroscopic

W.O.M. WORLD OF MEDICINE AG

The following data is part of a premarket notification filed by W.o.m. World Of Medicine Ag with the FDA for Hysteroscopy Pump Hm6.

Pre-market Notification Details

Device IDK123732
510k NumberK123732
Device Name:HYSTEROSCOPY PUMP HM6
ClassificationInsufflator, Hysteroscopic
Applicant W.O.M. WORLD OF MEDICINE AG 1480 CAMBRIDGE STREET Cambridge,  MA  02139
ContactSusanne Raab
CorrespondentSusanne Raab
W.O.M. WORLD OF MEDICINE AG 1480 CAMBRIDGE STREET Cambridge,  MA  02139
Product CodeHIG  
CFR Regulation Number884.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-05
Decision Date2013-04-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056702001629 K123732 000
04056702001612 K123732 000
04056702001599 K123732 000
04056702001582 K123732 000

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