The following data is part of a premarket notification filed by General Surgical Innovations with the FDA for Spacemaker Serial Surgical Balloon Dissector, With Cannula, With Visualization And With Visualization And Cannula.
| Device ID | K962702 |
| 510k Number | K962702 |
| Device Name: | SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GENERAL SURGICAL INNOVATIONS 3172-A PORTER DR. Palo Alto, CA 94304 |
| Contact | Cathleen Mantor |
| Correspondent | Cathleen Mantor GENERAL SURGICAL INNOVATIONS 3172-A PORTER DR. Palo Alto, CA 94304 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-12 |
| Decision Date | 1997-02-19 |
| Summary: | summary |