The following data is part of a premarket notification filed by Millipore Corp. with the FDA for Waters 650 Advanced Protein Purification System.
Device ID | K870949 |
510k Number | K870949 |
Device Name: | WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM |
Classification | Instrumentation, 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 | LDM |
CFR Regulation Number | 862.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-10 |
Decision Date | 1987-04-22 |