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FDA 510(k) Application Details - K103697
Device Classification Name
Handpiece, Contra- And Right-Angle Attachment, Dental
More FDA Info for this Device
510(K) Number
K103697
Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Applicant
J. MORITA USA, INC.
1425 K STREET NW
SUITE 1100
WASHINGTON, DC 20005 US
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Contact
KEITH A BARRITT
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EGS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/20/2010
Decision Date
01/20/2012
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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