The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Origin Tacker System.
| Device ID | K944415 |
| 510k Number | K944415 |
| Device Name: | ORIGIN TACKER SYSTEM |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Contact | Sandra V Diggs |
| Correspondent | Sandra V Diggs ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-08 |
| Decision Date | 1994-11-28 |