Pinpoint GT Needles

Needle, Conduction, Anesthetic (w/wo Introducer)

C.R. Bard, Inc.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Pinpoint Gt Needles.

Pre-market Notification Details

Device IDK163216
510k NumberK163216
Device Name:Pinpoint GT Needles
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant C.R. Bard, Inc. 605 North 5600 West Salt Lake City,  UT  84116
ContactSilvia De La Barra
CorrespondentSilvia De La Barra
C.R. Bard, Inc. 605 North 5600 West Salt Lake City,  UT  84116
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-16
Decision Date2017-06-27
Summary:summary

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