The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Mega Lumbar Puncture Kit.
| Device ID | K910089 |
| 510k Number | K910089 |
| Device Name: | MEGA LUMBAR PUNCTURE KIT |
| Classification | Manometer, Spinal-fluid |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. P.O.BOX 260956 Tampa, FL 33685 |
| Contact | Ellen Joy |
| Correspondent | Ellen Joy MEGADYNE MEDICAL PRODUCTS, INC. P.O.BOX 260956 Tampa, FL 33685 |
| Product Code | FMJ |
| CFR Regulation Number | 880.2500 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-09 |
| Decision Date | 1991-06-20 |