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FDA 510(k) Application Details - K113146
Device Classification Name
Varnish, Cavity
More FDA Info for this Device
510(K) Number
K113146
Device Name
Varnish, Cavity
Applicant
ROSS HEALTHCARE INC.
1750 GRANT AVE
BLAINE, WA 98230 US
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Contact
MARC N ROSS
Other 510(k) Applications for this Contact
Regulation Number
872.3260
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Classification Product Code
LBH
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More FDA Info for this Product Code
Date Received
10/24/2011
Decision Date
01/23/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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