PRIMED Pediatric Facemask— 510(k) K213427

Substantially Equivalent

Primed Medical Products, Inc.

FDA 510(k) clearance K213427 for PRIMED Pediatric Facemask, Substantially Equivalent on 2022-11-22. Applicant: Primed Medical Products, Inc..

Clearance details

Applicant: Primed Medical Products, Inc.
Product code: Code OXZ
Advisory panel: General, Plastic Surgery
Date received: 2021-10-21
Decision date: 2022-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edmonton, CA

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