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FDA 510(k) Application Details - K012744
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K012744
Device Name
Unit, Operative Dental
Applicant
MHT OPTIC RESEARCH AG
MANDACHSTR. 50
NIEDERHASLI CH-8155 CH
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Contact
MARKUS ANGST
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/16/2001
Decision Date
01/23/2002
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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