The following data is part of a premarket notification filed by General Surgical Innovations with the FDA for Spacemaker Surgicalballoon Dissector/expander.
| Device ID | K972109 |
| 510k Number | K972109 |
| Device Name: | SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER |
| Classification | Expander, Skin, Inflatable |
| Applicant | GENERAL SURGICAL INNOVATIONS 10460 BUBB RD. Cupertino, CA 95014 |
| Contact | Cathleen Mantor |
| Correspondent | Cathleen Mantor GENERAL SURGICAL INNOVATIONS 10460 BUBB RD. Cupertino, CA 95014 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-05 |
| Decision Date | 1997-11-14 |
| Summary: | summary |