Home / 510(k) Clearances / K111169

510(k) K111169

PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF by Kwang Myung Daicom, Inc. — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2011
Date Received
April 26, 2011
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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