The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Mega Myelogram Kit.
| Device ID | K913141 |
| 510k Number | K913141 |
| Device Name: | MEGA MYELOGRAM KIT |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. P.O.BOX 260956 Tampa, FL 33685 |
| Contact | Ray Vahab |
| Correspondent | Ray Vahab MEGADYNE MEDICAL PRODUCTS, INC. P.O.BOX 260956 Tampa, FL 33685 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-16 |
| Decision Date | 1991-10-17 |