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

Name: FDA 510(k) clearance K190308
Creator: U.S. Food and Drug Administration
Published: 2019-09-17

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.. Device class: 2.

Clearance details

Applicant: Amd Medicom, Inc.
Product code: Code OXZ
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2019-02-12
Decision date: 2019-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

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