The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Continuous Flow System, Cfs-1 Pump System (4-700-00).
| Device ID | K964196 |
| 510k Number | K964196 |
| Device Name: | CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin, IL 60123 |
| Contact | Casey Kurek |
| Correspondent | Casey Kurek NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin, IL 60123 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-21 |
| Decision Date | 1996-12-23 |
| Summary: | summary |