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FDA 510(k) Application Details - K121620
Device Classification Name
Drill, Bone, Powered
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510(K) Number
K121620
Device Name
Drill, Bone, Powered
Applicant
DMETEC CO., LTD.
4568 W. 1ST STREET
SUITE 104
LOS ANGELES, CA 90004 US
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Contact
DANIEL NAM
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Regulation Number
872.4120
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Classification Product Code
DZI
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More FDA Info for this Product Code
Date Received
06/01/2012
Decision Date
12/11/2012
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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