The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Origineedle(tm).
| Device ID | K904849 |
| 510k Number | K904849 |
| Device Name: | ORIGINEEDLE(TM) |
| Classification | Pneumoperitoneum Needle |
| Applicant | ORIGIN MEDSYSTEMS, INC. 1900 SOUTH NORFOLK STREET, SUITE 312 San Mateo, CA 94403 |
| Contact | Richard Rush |
| Correspondent | Richard Rush ORIGIN MEDSYSTEMS, INC. 1900 SOUTH NORFOLK STREET, SUITE 312 San Mateo, CA 94403 |
| Product Code | FHO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-26 |
| Decision Date | 1991-03-29 |