The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for System Controller 720 Series.
Device ID | K791661 |
510k Number | K791661 |
Device Name: | SYSTEM CONTROLLER 720 SERIES |
Classification | Apparatus, High Pressure Liquid Chromatography |
Applicant | WATERS ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KIE |
CFR Regulation Number | 862.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-21 |
Decision Date | 1979-09-24 |