FDA 510(k) Application Details - K022328

Device Classification Name Scaler, Ultrasonic

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510(K) Number K022328
Device Name Scaler, Ultrasonic
Applicant ELECTRO MEDICAL SYSTEMS SA
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 07/18/2002
Decision Date 08/13/2002
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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