The iMask Child's Face Mask— 510(k) K202831

Substantially Equivalent

Pac-Dent, Inc.

FDA 510(k) clearance K202831 for The iMask Child's Face Mask, Substantially Equivalent on 2021-08-26. Applicant: Pac-Dent, Inc..

Clearance details

Applicant: Pac-Dent, Inc.
Product code: Code OXZ
Advisory panel: General, Plastic Surgery
Date received: 2020-09-25
Decision date: 2021-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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