The following data is part of a premarket notification filed by Millipore Corp. with the FDA for Waters(tm) 996 Pda.
| Device ID | K924347 |
| 510k Number | K924347 |
| Device Name: | WATERS(TM) 996 PDA |
| Classification | Apparatus, High Pressure Liquid Chromatography |
| Applicant | MILLIPORE CORP. 34 MAPLE ST. Milford, MA 01757 |
| Contact | Marquand S Ransom |
| Correspondent | Marquand S Ransom MILLIPORE CORP. 34 MAPLE ST. Milford, MA 01757 |
| Product Code | KIE |
| CFR Regulation Number | 862.2260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-27 |
| Decision Date | 1992-12-11 |