The following data is part of a premarket notification filed by Dr. Japan Co., Ltd. with the FDA for Dr J Spinal And Epidural Needles.
| Device ID | K183316 |
| 510k Number | K183316 |
| Device Name: | Dr J Spinal And Epidural Needles |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Dr. Japan Co., Ltd. 1-1 Kagurazaka, Shinjuku-ku Tokyo, JP 162-0825 |
| Contact | Mitsuko Uchida |
| Correspondent | Yolanda Smith Smith Associates 1468 Harwell Ave Crofton, MD 21114 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-30 |
| Decision Date | 2019-08-12 |