K012991 is an FDA 510(k) clearance for the NEPTUNE WASTE MANAGEMENT STSTEM. This device is classified as a Apparatus, Exhaust, Surgical (Class II - Special Controls, product code FYD).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on November 29, 2001, 84 days after receiving the submission on September 6, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.5070.
| 510(k) Number | K012991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2001 |
| Decision Date | November 29, 2001 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYD — Apparatus, Exhaust, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5070 |