The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Evacuation Kit #7-510-14.
| Device ID | K914861 |
| 510k Number | K914861 |
| Device Name: | EVACUATION KIT #7-510-14 |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-29 |
| Decision Date | 1992-01-27 |