The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Continuous Epidural Anesthesia Tray/drug.
| Device ID | K802065 |
| 510k Number | K802065 |
| Device Name: | CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | PORTEX, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-27 |
| Decision Date | 1980-09-09 |