Omni Life Science, Inc. · Class II · Cleared Feb 18, 2009
| K-number | K082468 |
| Device name | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) |
| Applicant | Omni Life Science, Inc. |
| Product code | KWY |
| Device class | Class II |
| Decision date | Feb 18, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 888.3390 |
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