FDA 510(k) Application Details - K992504

Device Classification Name Scaler, Ultrasonic

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510(K) Number K992504
Device Name Scaler, Ultrasonic
Applicant (EMS SA) ELECTRO MEDICAL SYSTEMS
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact CYNTHIA J.M. NOLTE
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 07/27/1999
Decision Date 01/27/2000
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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