FDA 510(k)

Reverse Pull Adjustable Facemask

K-Number: K162543 · 2017-08-28

Decision Date2017-08-28

Product CodeDZB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Reverse Pull Adjustable Facemask is the device name listed in this FDA 510(k) record. The listed applicant is Sawbros Industries Pvt., Ltd.. It received FDA 510(k) clearance on 2017-08-28 under 510(k) 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. The listed applicant is Sawbros Industries Pvt., Ltd.. The 510(k) number is K162543.

When did Reverse Pull Adjustable Facemask receive FDA 510(k) clearance?

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

Who is the listed applicant for Reverse Pull Adjustable Facemask?

The FDA 510(k) record lists Sawbros Industries Pvt., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: DZB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202855Orthodontic FacemaskIta.O Italian Orthodontic System S.R.L.

Official Source

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