FDA 510(k) Application Details - K002521

Device Classification Name Scaler, Ultrasonic

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510(K) Number K002521
Device Name Scaler, Ultrasonic
Applicant SPARTAN MARKETING GROUP
1663 FENTON BUSINESS PARK CT.
FENTON, MO 63026 US
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Contact ALDO E EAGLE
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 08/15/2000
Decision Date 11/13/2000
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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