The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Universal General Use Kit #7-510-16.
| Device ID | K914401 |
| 510k Number | K914401 |
| Device Name: | UNIVERSAL GENERAL USE KIT #7-510-16 |
| Classification | Insufflator, Laparoscopic |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Contact | Peter A Manzie |
| Correspondent | Peter A Manzie 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 | 1991-10-02 |
| Decision Date | 1991-11-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817183020315 | K914401 | 000 |