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FDA 510(k) Application Details - K032708
Device Classification Name
Material, Impression
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510(K) Number
K032708
Device Name
Material, Impression
Applicant
SEPTODONT
1050 CONNECTICUT AVE., NW
WASHINGTON, DC 20036 US
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Contact
WAYNE H MATELSKI, ESQ.
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Regulation Number
872.3660
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Classification Product Code
ELW
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More FDA Info for this Product Code
Date Received
09/02/2003
Decision Date
11/20/2003
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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