The following data is part of a premarket notification filed by Amd Medicom, Inc. with the FDA for 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 .
| Device ID | K190308 |
| 510k 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 |
| Classification | Pediatric/child Facemask |
| Applicant | AMD Medicom, Inc. 2555 Chemin De L'Aviation, Pointe-Claire Montreal, CA H9p 2z2 |
| Contact | Ronald Reuben |
| Correspondent | Nektaria Markoglou AMD Medicom, Inc. 2555 Chemin De L'Aviation, Pointe-Claire Montreal, CA H9p 2z2 |
| Product Code | OXZ |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-12 |
| Decision Date | 2019-09-17 |