The following data is part of a premarket notification filed by Global Medikit Limited with the FDA for Medispine - Spinal Needle, Glospine - Spinal Needle.
| Device ID | K212982 |
| 510k Number | K212982 |
| Device Name: | Medispine - Spinal Needle, Glospine - Spinal Needle |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Global Medikit Limited Khasra No 323 MI, Camp Road, Selaqui, Dehradun, IN 248197 |
| Contact | Karun Narang |
| Correspondent | Atonu Dutta Alceon 201-203 Tilak Complex, Jetalpur Road Vadodara, IN 390007 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-17 |
| Decision Date | 2022-07-29 |