The following data is part of a premarket notification filed by Reganes, Inc. with the FDA for Reganes Disposable Epidural Anesthesia Tray.
| Device ID | K880181 |
| 510k Number | K880181 |
| Device Name: | REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY |
| Classification | Anesthesia Conduction Kit |
| Applicant | REGANES, INC. P.O. BOX 13212 Clearwater, FL 33519 |
| Contact | Joseph E Harms |
| Correspondent | Joseph E Harms REGANES, INC. P.O. BOX 13212 Clearwater, FL 33519 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-15 |
| Decision Date | 1988-02-11 |