The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Northgate Technologies Omniflator Model 6600.
| Device ID | K935862 |
| 510k Number | K935862 |
| Device Name: | NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600 |
| Classification | Insufflator, Laparoscopic |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Contact | Robert R Mantell |
| Correspondent | Robert R Mantell NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-03 |
| Decision Date | 1994-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554016451 | K935862 | 000 |