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510(k) K103019

KJ MASK by Kj Meditech Co., Ltd. — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2011
Date Received
October 12, 2010
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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