FDA 510(k) Application Details - K052090

Device Classification Name Material, Impression

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510(K) Number K052090
Device Name Material, Impression
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 872.3660

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Classification Product Code ELW
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Date Received 08/02/2005
Decision Date 08/05/2005
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 Y
Expedited Review



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