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 |