| K-number | K961342 |
| Device name | SHOE COVER, NON-STERILE |
| Applicant | Copioumed Intl., Inc. |
| Product code | FXP |
| Device class | Class I |
| Decision date | Dec 30, 1996 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
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