BIOSTIM-HV

Stimulator, Muscle, Powered

PROGRESSIVE CONCEPTS, INC.

The following data is part of a premarket notification filed by Progressive Concepts, Inc. with the FDA for Biostim-hv.

Pre-market Notification Details

Device IDK946298
510k NumberK946298
Device Name:BIOSTIM-HV
ClassificationStimulator, Muscle, Powered
Applicant PROGRESSIVE CONCEPTS, INC. 22194 HILLSBORO RD. Denton,  MD  21629
ContactW R Fischer
CorrespondentW R Fischer
PROGRESSIVE CONCEPTS, INC. 22194 HILLSBORO RD. Denton,  MD  21629
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-27
Decision Date1995-05-11

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