The following data is part of a premarket notification filed by Techniques Medicales De Navaree with the FDA for Polymedic Spinal Needle And Introducer.
Device ID | K940061 |
510k Number | K940061 |
Device Name: | POLYMEDIC SPINAL NEEDLE AND INTRODUCER |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | TECHNIQUES MEDICALES DE NAVAREE COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 -1109 |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein TECHNIQUES MEDICALES DE NAVAREE COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 -1109 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-06 |
Decision Date | 1995-12-21 |