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FDA 510(k)

Reverse Pull Adjustable Facemask

K-Number: K162543 · 2017-08-28

ApplicantSawbros Industries Pvt., Ltd.
Decision Date2017-08-28
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Reverse Pull Adjustable Facemask is a medical device manufactured by Sawbros Industries Pvt., Ltd.. It received FDA 510(k) clearance on 2017-08-28 under approval number K162543. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reverse Pull Adjustable Facemask?

Reverse Pull Adjustable Facemask is a medical device that received FDA 510(k) clearance on 2017-08-28. It is manufactured by Sawbros Industries Pvt., Ltd.. The 510(k) number is K162543.

When was Reverse Pull Adjustable Facemask approved by the FDA?

Reverse Pull Adjustable Facemask received FDA 510(k) clearance on 2017-08-28, under approval number K162543.

What company makes Reverse Pull Adjustable Facemask?

Reverse Pull Adjustable Facemask is manufactured by Sawbros Industries Pvt., Ltd..

What is the FDA product code for Reverse Pull Adjustable Facemask?

The FDA product code for Reverse Pull Adjustable Facemask is DZB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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