SURGIMOTOR

Motor, Surgical Instrument, Ac-powered

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 Surgimotor.

Pre-market Notification Details

Device IDK954470
510k NumberK954470
Device Name:SURGIMOTOR
ClassificationMotor, Surgical Instrument, Ac-powered
Applicant W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W. SUITE 900 WEST Washignton,  DC  20005 -3306
ContactRobert P Reznick
CorrespondentRobert P Reznick
W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W. SUITE 900 WEST Washignton,  DC  20005 -3306
Product CodeGEY  
CFR Regulation Number878.4820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-26
Decision Date1995-12-08

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