The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Preperitoneal Distention Balloon System.
| Device ID | K935426 |
| 510k Number | K935426 |
| Device Name: | PREPERITONEAL DISTENTION BALLOON SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Contact | A. Jill Schweiger |
| Correspondent | A. Jill Schweiger 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 | 1993-11-10 |
| Decision Date | 1994-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521067926 | K935426 | 000 |