NEUROPACE BURR HOLE COVER MODEL 8110

Cover, Burr Hole

NEUROPACE INC

The following data is part of a premarket notification filed by Neuropace Inc with the FDA for Neuropace Burr Hole Cover Model 8110.

Pre-market Notification Details

Device IDK123163
510k NumberK123163
Device Name:NEUROPACE BURR HOLE COVER MODEL 8110
ClassificationCover, Burr Hole
Applicant NEUROPACE INC 455 N. BERNARDO AVE Mountain View,  CA  94043
ContactIsabella Abati
CorrespondentIsabella Abati
NEUROPACE INC 455 N. BERNARDO AVE Mountain View,  CA  94043
Product CodeGXR  
CFR Regulation Number882.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-09
Decision Date2013-01-18
Summary:summary

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