The following data is part of a premarket notification filed by Avid N.i.t., Inc. with the FDA for Atraumatic Pencil Point Spinal Needle.
| Device ID | K945965 |
| 510k Number | K945965 |
| Device Name: | ATRAUMATIC PENCIL POINT SPINAL NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | AVID N.I.T., INC. 917 KLOSTERMAN RD. EAST Tarpon Springs, FL 34689 |
| Contact | Joseph E Harms |
| Correspondent | Joseph E Harms AVID N.I.T., INC. 917 KLOSTERMAN RD. EAST Tarpon Springs, FL 34689 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-07 |
| Decision Date | 1995-08-02 |