The following data is part of a premarket notification filed by General Surgical Innovations with the FDA for Spacemaker, Ii Surgical Balloon Dissector With And Without A Cannula.
| Device ID | K951878 |
| 510k Number | K951878 |
| Device Name: | SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A 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 | 1995-04-06 |
| Decision Date | 1995-06-29 |