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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K113146
Device Name PCXX VARNISH
Applicant
ROSS HEALTHCARE INC.
1750 GRANT AVE
BLAINE,  WA  98230
Applicant Contact MARC N ROSS
Correspondent
ROSS HEALTHCARE INC.
1750 GRANT AVE
BLAINE,  WA  98230
Correspondent Contact MARC N ROSS
Regulation Number872.3260
Classification Product Code
LBH  
Date Received10/24/2011
Decision Date 01/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product Yes
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