Primeline Medical Products, Inc. · Class II · Cleared Sep 8, 2000
| K-number | K001951 |
| Device name | PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306 |
| Applicant | Primeline Medical Products, Inc. |
| Product code | FXX |
| Device class | Class II |
| Decision date | Sep 8, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
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