The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Hydrotower Arthroscopic Administration Tubing Set, Model 7-460-05.
| Device ID | K011928 |
| 510k Number | K011928 |
| Device Name: | HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-20 |
| Decision Date | 2001-08-10 |
| Summary: | summary |