Exact Medical Manufacturing, Inc. · Class II · Cleared Sep 3, 2010
| K-number | K101593 |
| Device name | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL |
| Applicant | Exact Medical Manufacturing, Inc. |
| Product code | FYA |
| Device class | Class II |
| Decision date | Sep 3, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
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