K904156 is an FDA 510(k) clearance for the ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS. This device is classified as a System, Cement Removal Extraction (Class II - Special Controls, product code LZV).
Submitted by Origin Medsystems, Inc. (San Mateo, US). The FDA issued a Cleared decision on November 27, 1990, 81 days after receiving the submission on September 7, 1990.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4580.
| 510(k) Number | K904156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1990 |
| Decision Date | November 27, 1990 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LZV — System, Cement Removal Extraction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.4580 |