Smith & Nephew, Inc. · Class II · Cleared Mar 15, 2002
| K-number | K012788 |
| Device name | VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II |
| Applicant | Smith & Nephew, Inc. |
| Product code | KWS |
| Device class | Class II |
| Decision date | Mar 15, 2002 |
| Decision | Substantially Equivalent |
| Regulation | 888.3660 |
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