The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Evacuator, Gastro-urology.
| Device ID | K921088 |
| 510k Number | K921088 |
| Device Name: | EVACUATOR, GASTRO-UROLOGY |
| Classification | Evacuator, Gastro-urology |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Product Code | KQT |
| CFR Regulation Number | 876.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-06 |
| Decision Date | 1992-10-28 |