GV 11 (TM), MODEL 9700

Stimulator, Muscle, Powered

MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Gv 11 (tm), Model 9700.

Pre-market Notification Details

Device IDK881082
510k NumberK881082
Device Name:GV 11 (TM), MODEL 9700
ClassificationStimulator, Muscle, Powered
Applicant MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul,  MN  55112
ContactBruce Macfarlane,phd
CorrespondentBruce Macfarlane,phd
MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul,  MN  55112
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-14
Decision Date1988-03-28

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