The following data is part of a premarket notification filed by Myco Medical Supplies, Inc. with the FDA for Reli Nrfit Epidural Needles, Phoenix Nrfit Epidural Needles, Reli Nrfit Spinal Needles, Phoenix Nrfit Spinal Needles.
| Device ID | K203668 |
| 510k Number | K203668 |
| Device Name: | RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | MYCO Medical Supplies, Inc. 2015 Production Drive Apex, NC 27539 |
| Contact | Sanjiv Krumar |
| Correspondent | E.j. 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 | 2020-12-16 |
| Decision Date | 2021-09-29 |