SURGIFLATOR

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.

Pre-market Notification Details

Device IDK921264
510k NumberK921264
Device Name:SURGIFLATOR
ClassificationInsufflator, Laparoscopic
Applicant W.O.M. WORLD OF MEDICINE, GMBH 8536 CALLE TIOGA Tucson,  AR  85704
ContactOwen B Lamb
CorrespondentOwen B Lamb
W.O.M. WORLD OF MEDICINE, GMBH 8536 CALLE TIOGA Tucson,  AR  85704
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-16
Decision Date1992-10-09

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