510(k) K190308 ยท OXZ Pediatric/Child Facemask
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
| Applicant | Amd Medicom, Inc., Montreal, CA |
| Decision | Substantially Equivalent, Sep 17, 2019 |
| Received | Feb 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190308
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.