The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Laparoview.
| Device ID | K931065 |
| 510k Number | K931065 |
| Device Name: | LAPAROVIEW |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Contact | Kenneth J Sikora |
| Correspondent | Kenneth J Sikora NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-01 |
| Decision Date | 1994-11-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LAPAROVIEW 74307349 not registered Dead/Abandoned |
Northgate Technologies, Inc. 1992-08-24 |