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)— 510(k) K190308

Substantially Equivalent

Amd Medicom, Inc.

FDA 510(k) clearance K190308 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 Pediatric Procedure Earloop Face Masks (ASTM Level 1), Substantially Equivalent on 2019-09-17. Applicant: Amd Medicom, Inc..

Clearance details

Applicant: Amd Medicom, Inc.
Product code: Code OXZ
Advisory panel: General, Plastic Surgery
Date received: 2019-02-12
Decision date: 2019-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

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