The following data is part of a premarket notification filed by Myco Medical, Inc. with the FDA for Dr. Japan Facil Point Spinal Needle.
| Device ID | K020934 |
| 510k Number | K020934 |
| Device Name: | DR. JAPAN FACIL POINT SPINAL NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | MYCO MEDICAL, INC. 113 CENTRE WEST COURT Cary, NC 27513 |
| Contact | Sam Kumar |
| Correspondent | Sam Kumar MYCO MEDICAL, INC. 113 CENTRE WEST COURT 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 | 2002-03-22 |
| Decision Date | 2002-10-25 |