K910089 is an FDA 510(k) clearance for the MEGA LUMBAR PUNCTURE KIT. This device is classified as a Manometer, Spinal-fluid (Class II - Special Controls, product code FMJ).
Submitted by Megadyne Medical Products, Inc. (Tampa, US). The FDA issued a Cleared decision on June 20, 1991, 162 days after receiving the submission on January 9, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2500.
| 510(k) Number | K910089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | January 09, 1991 |
| Decision Date | June 20, 1991 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMJ — Manometer, Spinal-fluid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2500 |