SURGIFLATOR-20 ECU

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 Surgiflator-20 Ecu.

Pre-market Notification Details

Device IDK981859
510k NumberK981859
Device Name:SURGIFLATOR-20 ECU
ClassificationInsufflator, Laparoscopic
Applicant W.O.M. WORLD OF MEDICINE, GMBH 1775 I STREET, N.W. Washington,  DC  20006 -2401
ContactRobert P Reznick
CorrespondentRobert P Reznick
W.O.M. WORLD OF MEDICINE, GMBH 1775 I STREET, N.W. Washington,  DC  20006 -2401
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-27
Decision Date1998-06-26
Summary:summary

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