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FDA 510(k) Application Details - K970649
Device Classification Name
File, Pulp Canal, Endodontic
More FDA Info for this Device
510(K) Number
K970649
Device Name
File, Pulp Canal, Endodontic
Applicant
MICRO-MEGA
5-12 RUE DU TUNNEL
25006 BESANCON
FRANCE FR
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Contact
JM BADOZ
Other 510(k) Applications for this Contact
Regulation Number
872.4565
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Classification Product Code
EKS
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More FDA Info for this Product Code
Date Received
02/20/1997
Decision Date
05/16/1997
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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