The following data is part of a premarket notification filed by General Surgical Innovations with the FDA for The Reusable Spacemaker Surgical Balloon Dissector & Cannula.
| Device ID | K952278 |
| 510k Number | K952278 |
| Device Name: | THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GENERAL SURGICAL INNOVATIONS 3172A PORTER DR. Palo Alto, CA 94304 |
| Contact | Theresa Nazaroff |
| Correspondent | Theresa Nazaroff GENERAL SURGICAL INNOVATIONS 3172A 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 | 1995-05-15 |
| Decision Date | 1995-08-07 |