The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for General Use Kit #7-510-20.
| Device ID | K914403 |
| 510k Number | K914403 |
| Device Name: | GENERAL USE KIT #7-510-20 |
| 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 |
|---|---|---|
| 10817183020346 | K914403 | 000 |
| 10817183020339 | K914403 | 000 |
| 10817183020322 | K914403 | 000 |
| 10817183020308 | K914403 | 000 |
| 23596010463818 | K914403 | 000 |
| 03596010463821 | K914403 | 000 |
| 03596010126795 | K914403 | 000 |
| 00817183020707 | K914403 | 000 |