General Surgical Innovations · Class II · Cleared Jan 16, 1998
| K-number | K973046 |
| Device name | SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK |
| Applicant | General Surgical Innovations |
| Product code | GCJ |
| Device class | Class II |
| Decision date | Jan 16, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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