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FDA 510(k) Application Details - K113530
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K113530
Device Name
Scaler, Ultrasonic
Applicant
NAKANISHI, INC.
1201 RICHARDSON DRIVE
SUITE 280
RICHARDSON, TX 75080 US
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Contact
DIANE RUTHERFORD
Other 510(k) Applications for this Contact
Regulation Number
872.4850
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Classification Product Code
ELC
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More FDA Info for this Product Code
Date Received
11/30/2011
Decision Date
01/31/2013
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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