EPIDURAL NEEDLE

Needle, Conduction, Anesthetic (w/wo Introducer)

SPINAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Spinal Specialties, Inc. with the FDA for Epidural Needle.

Pre-market Notification Details

Device IDK942863
510k NumberK942863
Device Name:EPIDURAL NEEDLE
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio,  TX  78217
ContactRobert Keahney
CorrespondentRobert Keahney
SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio,  TX  78217
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-17
Decision Date1995-08-11

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