The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Pajunk Standard Sprotte Needle W/ Introducer Cann..
| Device ID | K923003 |
| 510k Number | K923003 |
| Device Name: | PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN. |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Richard T Lykins |
| Correspondent | Richard T Lykins RUSCH, INC. TALL PINES PARK Jaffrey, 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 | 1992-06-22 |
| Decision Date | 1993-04-15 |