FDA 510(k) Application Details - K051776

Device Classification Name Scaler, Ultrasonic

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510(K) Number K051776
Device Name Scaler, Ultrasonic
Applicant DISCUS DENTAL INC.
8550 HIGUERA ST.
CULVER CITY, CA 90232 US
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Contact SUZANNE RIDGWAY
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 07/01/2005
Decision Date 07/13/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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