The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Preperitoneal Distention Balloon Systems (modification).
| Device ID | K953561 |
| 510k Number | K953561 |
| Device Name: | PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Contact | Richard D Rush |
| Correspondent | Richard D Rush ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-14 |
| Decision Date | 1995-08-11 |