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FDA 510(k) Application Details - K071447
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K071447
Device Name
Scaler, Ultrasonic
Applicant
NAKANISHI, INC.
700 SHIMOHINATA
KANUMA-SHI, TOCHIGI-KEN 322-8666 JP
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Contact
TOMOKO HIRABAYASHI
Other 510(k) Applications for this Contact
Regulation Number
872.4850
More FDA Info for this Regulation Number
Classification Product Code
ELC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/24/2007
Decision Date
04/18/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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