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 |