The following data is part of a premarket notification filed by Top Surgical Manufacturers Co. with the FDA for Top Disposable Spinal Needle.
| Device ID | K843313 |
| 510k Number | K843313 |
| Device Name: | TOP DISPOSABLE SPINAL NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | TOP SURGICAL MANUFACTURERS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-24 |
| Decision Date | 1984-09-19 |