FDA 510(k)

POLYMEDIC SPINAL NEEDLE AND INTRODUCER

K-Number: K940061 · 1995-12-21

ApplicantTechniques Medicales DE Navaree

Decision Date1995-12-21

Product CodeBSP

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

POLYMEDIC SPINAL NEEDLE AND INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Techniques Medicales DE Navaree. It received FDA 510(k) clearance on 1995-12-21 under 510(k) number K940061. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYMEDIC SPINAL NEEDLE AND INTRODUCER?

POLYMEDIC SPINAL NEEDLE AND INTRODUCER is a medical device that received FDA 510(k) clearance on 1995-12-21. The listed applicant is Techniques Medicales DE Navaree. The 510(k) number is K940061.

When did POLYMEDIC SPINAL NEEDLE AND INTRODUCER receive FDA 510(k) clearance?

POLYMEDIC SPINAL NEEDLE AND INTRODUCER received FDA 510(k) clearance on 1995-12-21, under 510(k) number K940061.

Who is the listed applicant for POLYMEDIC SPINAL NEEDLE AND INTRODUCER?

The FDA 510(k) record lists Techniques Medicales DE Navaree as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYMEDIC SPINAL NEEDLE AND INTRODUCER?

The FDA product code for POLYMEDIC SPINAL NEEDLE AND INTRODUCER is BSP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.