FDA 510(k) Application Details - K032995

Device Classification Name Scaler, Ultrasonic

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510(K) Number K032995
Device Name Scaler, Ultrasonic
Applicant MICRON CORP.
1-34-14 HIGASHIYUKIGAYA
OTA-KU, TOKYO 145-0065 JP
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Contact TAKASHI TERUI
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 09/25/2003
Decision Date 11/20/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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