NEURO-AIDE

Pinwheel

BURKE NEUTECH, INC.

The following data is part of a premarket notification filed by Burke Neutech, Inc. with the FDA for Neuro-aide.

Pre-market Notification Details

Device IDK942926
510k NumberK942926
Device Name:NEURO-AIDE
ClassificationPinwheel
Applicant BURKE NEUTECH, INC. 11701 S. BELCHER RD. SUITE 119 Largo,  FL  34643 -5117
ContactRobert E Burke
CorrespondentRobert E Burke
BURKE NEUTECH, INC. 11701 S. BELCHER RD. SUITE 119 Largo,  FL  34643 -5117
Product CodeGWY  
CFR Regulation Number882.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-22
Decision Date1994-08-03

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