FDA 510(k) Application Details - K983029

Device Classification Name Scaler, Ultrasonic

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510(K) Number K983029
Device Name Scaler, Ultrasonic
Applicant TPC ADVANCED TECHNOLOGY, INC.
18140 SMOKESIGNAL DR.
SAN DIEGO, CA 92127 US
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Contact CAROL PATTERSON
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 08/31/1998
Decision Date 01/29/1999
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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