FDA 510(k) Application Details - K990546

Device Classification Name Scaler, Ultrasonic

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510(K) Number K990546
Device Name Scaler, Ultrasonic
Applicant SDS DENTAL, INC.
5101 N.W. 21ST AVE. N.W.
SUITE 141
FORT LAUDERDALE, FL 33309 US
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Contact CESAR CORAL
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 02/22/1999
Decision Date 11/05/1999
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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