The following data is part of a premarket notification filed by Waters Corporation with the FDA for Waters 515 Hplc Pump (515).
| Device ID | K964588 |
| 510k Number | K964588 |
| Device Name: | WATERS 515 HPLC PUMP (515) |
| Classification | Apparatus, High Pressure Liquid Chromatography |
| Applicant | WATERS CORPORATION 34 MAPLE ST. Milford, MA 01757 -3696 |
| Contact | Virginia L Corbin |
| Correspondent | Virginia L Corbin WATERS CORPORATION 34 MAPLE ST. Milford, MA 01757 -3696 |
| Product Code | KIE |
| CFR Regulation Number | 862.2260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-15 |
| Decision Date | 1996-11-29 |