The following data is part of a premarket notification filed by General Surgical Innovations with the FDA for Surgical Dissector With Cannula.
Device ID | K926010 |
510k Number | K926010 |
Device Name: | SURGICAL DISSECTOR WITH CANNULA |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | GENERAL SURGICAL INNOVATIONS 3278 ALPINE RD. Portola Valley, CA 94028 |
Contact | Thomas J Fogarty |
Correspondent | Thomas J Fogarty GENERAL SURGICAL INNOVATIONS 3278 ALPINE RD. Portola Valley, CA 94028 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-27 |
Decision Date | 1993-06-25 |