The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Origineedle, Modification.
| Device ID | K913816 |
| 510k Number | K913816 |
| Device Name: | ORIGINEEDLE, MODIFICATION |
| Classification | Pneumoperitoneum Needle |
| Applicant | ORIGIN MEDSYSTEMS, INC. 1900 SOUTH NORFOLK STREET, SUITE 312 San Mateo, CA 94403 |
| Contact | Frederic H Moll |
| Correspondent | Frederic H Moll 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 | 1991-08-26 |
| Decision Date | 1991-11-08 |