The following data is part of a premarket notification filed by Ocean Medical Products, Ltd. with the FDA for Spinal Needle.
| Device ID | K823692 |
| 510k Number | K823692 |
| Device Name: | SPINAL NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | OCEAN MEDICAL PRODUCTS, LTD. 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 | 1982-12-08 |
| Decision Date | 1983-01-07 |