POLYMEDIC SPINAL NEEDLE AND INTRODUCER

Needle, Conduction, Anesthetic (w/wo Introducer)

TECHNIQUES MEDICALES DE NAVAREE

The following data is part of a premarket notification filed by Techniques Medicales De Navaree with the FDA for Polymedic Spinal Needle And Introducer.

Pre-market Notification Details

Device IDK940061
510k NumberK940061
Device Name:POLYMEDIC SPINAL NEEDLE AND INTRODUCER
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant TECHNIQUES MEDICALES DE NAVAREE COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington,  DC  20004 -1109
ContactHoward M Holstein
CorrespondentHoward M Holstein
TECHNIQUES MEDICALES DE NAVAREE COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington,  DC  20004 -1109
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-06
Decision Date1995-12-21

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