The following data is part of a premarket notification filed by Alexander Medical, Inc. with the FDA for Epidural Mini Kit, Eldor Combined Spinal/epidural Kit.
| Device ID | K964783 |
| 510k Number | K964783 |
| Device Name: | EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT |
| Classification | Anesthesia Conduction Kit |
| Applicant | ALEXANDER MEDICAL, INC. 15828 SHADY GROVE RD. SUITE 130 Rockville, MD 20841 |
| Contact | Kenneth A Palmer |
| Correspondent | Kenneth A Palmer ALEXANDER MEDICAL, INC. 15828 SHADY GROVE RD. SUITE 130 Rockville, MD 20841 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-27 |
| Decision Date | 1997-02-12 |
| Summary: | summary |