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FDA 510(k) Application Details - K072577
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K072577
Device Name
Material, Impression
Applicant
BISICO GMBH & CO KG
AMSTEL 320-I
AMSTERDAM 33611 NL
Other 510(k) Applications for this Company
Contact
DAGMAR MAESER
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
09/13/2007
Decision Date
12/05/2007
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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