K960405 is an FDA 510(k) clearance for the SPINAL NEEDLE. This device is classified as a Needle, Spinal, Short Term (Class II - Special Controls, product code MIA).
Submitted by Promex, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 28, 1996, 30 days after receiving the submission on January 29, 1996.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5150.
| 510(k) Number | K960405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1996 |
| Decision Date | February 28, 1996 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | MIA — Needle, Spinal, Short Term |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5150 |