K970287 is an FDA 510(k) clearance for the LUMBAR PUNCTURE KIT. This device is classified as a Manometer, Spinal-fluid (Class II - Special Controls, product code FMJ).
Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 7, 1997, 73 days after receiving the submission on January 24, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2500.
| 510(k) Number | K970287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1997 |
| Decision Date | April 07, 1997 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMJ — Manometer, Spinal-fluid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2500 |