The following data is part of a premarket notification filed by Waters Chemical Products with the FDA for High Pressure Inert Plastic Columns For Clin. Use.
| Device ID | K895105 |
| 510k Number | K895105 |
| Device Name: | HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE |
| Classification | Columns, Liquid Chromatography |
| Applicant | WATERS CHEMICAL PRODUCTS 34 MAPLE ST. Milford, MA 01757 |
| Contact | Marquand Ransom |
| Correspondent | Marquand Ransom WATERS CHEMICAL PRODUCTS 34 MAPLE ST. Milford, MA 01757 |
| Product Code | DPM |
| CFR Regulation Number | 862.2260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-15 |
| Decision Date | 1989-10-06 |