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510(k) K162543

Reverse Pull Adjustable Facemask by Sawbros Industries Pvt., Ltd. — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2017
Date Received
September 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headgear, Extraoral, Orthodontic
Device Class
Class II
Regulation Number
872.5500
Review Panel
DE
Submission Type

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