The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Epidural Catheter Models 1210/1200.
| Device ID | K983125 |
| 510k Number | K983125 |
| Device Name: | EPIDURAL CATHETER MODELS 1210/1200 |
| Classification | Anesthesia Conduction Kit |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | James R Whitney |
| Correspondent | James R Whitney RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-08 |
| Decision Date | 1998-11-17 |
| Summary: | summary |