The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Ballpen Spinal Needle W/wo Introducer.
| Device ID | K011122 |
| 510k Number | K011122 |
| Device Name: | BALLPEN SPINAL NEEDLE W/WO INTRODUCER |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | RUSCH INTL. 50 PLANTATION DR. Jaffery, NH 03452 |
| Contact | Julie A Beaumont |
| Correspondent | Julie A Beaumont RUSCH INTL. 50 PLANTATION DR. Jaffery, NH 03452 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-12 |
| Decision Date | 2001-11-16 |