The following data is part of a premarket notification filed by Reganes, Inc. with the FDA for Epidural Anesthesia Needles.
| Device ID | K854816 |
| 510k Number | K854816 |
| Device Name: | EPIDURAL ANESTHESIA NEEDLES |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| 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 | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-03 |
| Decision Date | 1985-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20809160324353 | K854816 | 000 |
| 40193489902823 | K854816 | 000 |
| 20809160323486 | K854816 | 000 |
| 20809160323493 | K854816 | 000 |
| 20809160324247 | K854816 | 000 |
| 20809160324261 | K854816 | 000 |
| 20809160324278 | K854816 | 000 |
| 20809160324285 | K854816 | 000 |
| 20809160324292 | K854816 | 000 |
| 20809160324308 | K854816 | 000 |
| 20809160324315 | K854816 | 000 |
| 20809160324322 | K854816 | 000 |
| 20809160324339 | K854816 | 000 |
| 20809160324346 | K854816 | 000 |
| M661S885183501 | K854816 | 000 |