The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Omniflator 7640 Model 7-640-00.
| Device ID | K983326 |
| 510k Number | K983326 |
| Device Name: | OMNIFLATOR 7640 MODEL 7-640-00 |
| Classification | Insufflator, Laparoscopic |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin, IL 60123 |
| Contact | Cassey Kurek |
| Correspondent | Cassey 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 | 1998-09-22 |
| Decision Date | 1999-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817183020353 | K983326 | 000 |
| 00885556568125 | K983326 | 000 |
| 20845854045340 | K983326 | 000 |