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FDA 510(k) Application Details - K103019
Device Classification Name
Headgear, Extraoral, Orthodontic
More FDA Info for this Device
510(K) Number
K103019
Device Name
Headgear, Extraoral, Orthodontic
Applicant
KJ MEDITECH CO., LTD
951 STARBUCK ST.
UNIT J
FULLERTON, CA 92833 US
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Contact
Priscilla Chung
Other 510(k) Applications for this Contact
Regulation Number
872.5500
More FDA Info for this Regulation Number
Classification Product Code
DZB
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More FDA Info for this Product Code
Date Received
10/12/2010
Decision Date
06/09/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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