Omnlife Science · Class II · Cleared May 28, 2010
| K-number | K100151 |
| Device name | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) |
| Applicant | Omnlife Science |
| Product code | KWY |
| Device class | Class II |
| Decision date | May 28, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 888.3390 |
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