Amd Medicom, Inc. · Class II · Cleared Sep 17, 2019
| K-number | K190308 |
| Device name | Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) |
| Applicant | Amd Medicom, Inc. |
| Product code | OXZ |
| Device class | Class II |
| Decision date | Sep 17, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
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