The following data is part of a premarket notification filed by General Surgical Innovations with the FDA for Gsi Cannula With Introducer.
| Device ID | K970201 |
| 510k Number | K970201 |
| Device Name: | GSI CANNULA WITH INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | GENERAL SURGICAL INNOVATIONS 3172A PORTER DR. Palo Alto, CA 94304 |
| Contact | Cathleen Mantor |
| Correspondent | Cathleen Mantor GENERAL SURGICAL INNOVATIONS 3172A PORTER DR. Palo Alto, CA 94304 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-04-21 |
| Summary: | summary |