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FDA 510(k) Application Details - K061689
Device Classification Name
Cleanser, Root Canal
More FDA Info for this Device
510(K) Number
K061689
Device Name
Cleanser, Root Canal
Applicant
PURICORE, INC.
320 KING OF PRUSSIA ROAD
SUITE 200
RADNOR, PA 19087 US
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Contact
HOWARD MANN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KJJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/15/2006
Decision Date
08/24/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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