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FDA 510(k) Application Details - K031793
Device Classification Name
Saw, Bone, Ac-Powered
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510(K) Number
K031793
Device Name
Saw, Bone, Ac-Powered
Applicant
DENTATUS USA, LTD.
30 NORTHPORT ROAD
SOUND BEACH, NY 11789-1734 US
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Contact
RICHARD C LANZILLOTTO
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Regulation Number
872.4120
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Classification Product Code
DZH
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More FDA Info for this Product Code
Date Received
06/10/2003
Decision Date
11/13/2003
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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