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FDA 510(k) Application Details - K141886
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K141886
Device Name
Handpiece, Air-Powered, Dental
Applicant
MODERN KOREA CO., LTD.
2651 E. CHAPMAN AVE. STE 110
FULLERTON, CA 92831 US
Other 510(k) Applications for this Company
Contact
Priscilla Chung
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EFB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/14/2014
Decision Date
05/13/2015
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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