The following data is part of a premarket notification filed by Myco Medical Supplies, Inc. with the FDA for Phoenix Epidural & Spinal Needles.
| Device ID | K990519 |
| 510k Number | K990519 |
| Device Name: | PHOENIX EPIDURAL & SPINAL NEEDLES |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | MYCO MEDICAL SUPPLIES, INC. 101 ROSE VALLEY WOODS DR. Cary, NC 27513 |
| Contact | Sanjiv Kumar |
| Correspondent | Sanjiv Kumar MYCO MEDICAL SUPPLIES, INC. 101 ROSE VALLEY WOODS DR. Cary, NC 27513 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-18 |
| Decision Date | 2000-06-02 |