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FDA 510(k) Application Details - K052090
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K052090
Device Name
Material, Impression
Applicant
DISCUS DENTAL INC.
8550 HIGUERA ST.
CULVER CITY, CA 90232 US
Other 510(k) Applications for this Company
Contact
SUZANNE RIDGWAY
Other 510(k) Applications for this Contact
Regulation Number
872.3660
More FDA Info for this Regulation Number
Classification Product Code
ELW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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