The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Arthroscopic Tubing Sheath.
| Device ID | K896584 |
| 510k Number | K896584 |
| Device Name: | ARTHROSCOPIC TUBING SHEATH |
| Classification | Arthroscope |
| Applicant | ORIGIN MEDSYSTEMS, INC. 1900 SOUTH NORFOLK STREET, SUITE 312 San Mateo, CA 94403 |
| Contact | Chin, M.d. |
| Correspondent | Chin, M.d. ORIGIN MEDSYSTEMS, INC. 1900 SOUTH NORFOLK STREET, SUITE 312 San Mateo, CA 94403 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-21 |
| Decision Date | 1989-12-27 |