Reverse Pull Adjustable Facemask— 510(k) K162543

Name: FDA 510(k) clearance K162543
Creator: U.S. Food and Drug Administration
Published: 2017-08-28

Substantially Equivalent

Sawbros Industries Pvt., Ltd.

FDA 510(k) clearance K162543 for Reverse Pull Adjustable Facemask, Substantially Equivalent on 2017-08-28. Applicant: Sawbros Industries Pvt., Ltd.. Device class: 2.

Clearance details

Applicant: Sawbros Industries Pvt., Ltd.
Product code: Code DZB
Device class: Class 2
Regulation: 21 CFR 872.5500
Advisory panel: Dental
Date received: 2016-09-12
Decision date: 2017-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Noida, IN

Download summary PDF View on FDA.gov ↗

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