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FDA 510(k) Application Details - K043054
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K043054
Device Name
Material, Impression
Applicant
SULTAN CHEMISTS, INC.
85 WEST FOREST AVE.
ENGLEWOOD, NJ 07631 US
Other 510(k) Applications for this Company
Contact
CLARK SMITH
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
11/05/2004
Decision Date
02/18/2005
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
N
Expedited Review
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