The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Neptune 3 Waste Management System.
| Device ID | K153407 |
| 510k Number | K153407 |
| Device Name: | Stryker Neptune 3 Waste Management System |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
| Contact | Kim Wiersema |
| Correspondent | Kim Wiersema STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-25 |
| Decision Date | 2016-04-25 |
| Summary: | summary |