The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Dissection Probe.
| Device ID | K955163 |
| 510k Number | K955163 |
| Device Name: | DISSECTION PROBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Contact | Albert K Chin |
| Correspondent | Albert K Chin ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-01-24 |