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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pediatric/child facemask
510(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 Leve
Applicant
AMD Medicom, Inc.
2555 Chemin de l'Aviation,
Pointe-Claire
Montreal,  CA H9P 2Z2
Applicant Contact Ronald Reuben
Correspondent
AMD Medicom, Inc.
2555 Chemin de l'Aviation,
Pointe-Claire
Montreal,  CA H9P 2Z2
Correspondent Contact Nektaria Markoglou
Regulation Number878.4040
Classification Product Code
OXZ  
Date Received02/12/2019
Decision Date 09/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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