The following data is part of a premarket notification filed by Mega Medical, Inc. with the FDA for Mega Spinal Anesthesia Kit.
| Device ID | K912322 |
| 510k Number | K912322 |
| Device Name: | MEGA SPINAL ANESTHESIA KIT |
| Classification | Anesthesia Conduction Kit |
| Applicant | MEGA MEDICAL, INC. P.O. BOX 260956 Tampa, FL 33685 |
| Contact | Ellen Jooy |
| Correspondent | Ellen Jooy MEGA MEDICAL, INC. P.O. BOX 260956 Tampa, FL 33685 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-24 |
| Decision Date | 1991-09-26 |