The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Flo-assistant.
| Device ID | K041560 |
| 510k Number | K041560 |
| Device Name: | FLO-ASSISTANT |
| Classification | Insufflator, Laparoscopic |
| 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 | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-10 |
| Decision Date | 2004-09-28 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FLO-ASSISTANT 78420172 not registered Dead/Abandoned |
Northgate Technologies Inc. 2004-05-17 |
![]() FLO-ASSISTANT 77664355 not registered Dead/Abandoned |
Northgate Technologies Inc. 2009-02-05 |