The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Origin(tm) Cement Extract Syst Std-pr/spl-pr Kits.
| Device ID | K904156 |
| 510k Number | K904156 |
| Device Name: | ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS |
| Classification | System, Cement Removal Extraction |
| 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 | LZV |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-07 |
| Decision Date | 1990-11-27 |