FDA 510(k) Application Details - K002122

Device Classification Name Scaler, Ultrasonic

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510(K) Number K002122
Device Name Scaler, Ultrasonic
Applicant AIR TECHNIQUES, INC.
70 CANTIAGUE ROCK RD.
HICKSVILLE, NY 11801 US
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Contact JOSEPH CAREY
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 07/13/2000
Decision Date 12/21/2000
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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