The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Omniflator 6630(6-630-00).
| Device ID | K973447 |
| 510k Number | K973447 |
| Device Name: | OMNIFLATOR 6630(6-630-00) |
| 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 | 1997-09-11 |
| Decision Date | 1998-09-30 |
| Summary: | summary |