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FDA 510(k) Application Details - K093971
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K093971
Device Name
Handpiece, Air-Powered, Dental
Applicant
NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD.
# 19, LANE 999 ZHONGSHAN 2 RD
SUITE 8D
SHANGHAI 200030 CN
Other 510(k) Applications for this Company
Contact
Diana Hong
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
12/24/2009
Decision Date
04/22/2010
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
Y
Expedited Review
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