The following data is part of a premarket notification filed by Adjacent Surgical, Inc. with the FDA for Spacemaker Surgical Balloon Dissector With Cannula & The Spacemaker Ii Surgical Balloon Dissector With Cannula.
| Device ID | K952444 |
| 510k Number | K952444 |
| Device Name: | SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ADJACENT SURGICAL, INC. 10231 BUBB RD. Cupertino, CA 95014 |
| Contact | Shelly Y Monfort |
| Correspondent | Shelly Y Monfort ADJACENT SURGICAL, INC. 10231 BUBB RD. Cupertino, CA 95014 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-25 |
| Decision Date | 1995-08-07 |