HYSTEREOSCOPY PUMP HM4

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 Hystereoscopy Pump Hm4.

Pre-market Notification Details

Device IDK022449
510k NumberK022449
Device Name:HYSTEREOSCOPY PUMP HM4
ClassificationInsufflator, Hysteroscopic
Applicant W.O.M. WORLD OF MEDICINE AG 91 TROWBRIDGE ST. Cambridge,  MA  02138
ContactSusanne Raab
CorrespondentSusanne Raab
W.O.M. WORLD OF MEDICINE AG 91 TROWBRIDGE ST. Cambridge,  MA  02138
Product CodeHIG  
CFR Regulation Number884.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-26
Decision Date2003-04-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056702004507 K022449 000
04056702004484 K022449 000
04056702002534 K022449 000
04056702002367 K022449 000
04056702002329 K022449 000
04056702000783 K022449 000
04056702000769 K022449 000
04056702000097 K022449 000

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