The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Neptune Waste Management Ststem.
| Device ID | K012991 |
| 510k Number | K012991 |
| Device Name: | NEPTUNE WASTE MANAGEMENT STSTEM |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Suzanne Velazquez |
| Correspondent | Suzanne Velazquez STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-06 |
| Decision Date | 2001-11-29 |