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FDA 510(k) Application Details - K972875
Device Classification Name
Post, Root Canal
More FDA Info for this Device
510(K) Number
K972875
Device Name
Post, Root Canal
Applicant
IVOCLAR NORTH AMERICA, INC.
175 PINEVIEW DR.
AMHERST, NY 14228 US
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Contact
PETER P MANCUSO
Other 510(k) Applications for this Contact
Regulation Number
872.3810
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Classification Product Code
ELR
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More FDA Info for this Product Code
Date Received
08/04/1997
Decision Date
09/17/1997
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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