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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
Predetermined Change
Control Plan Authorized		 No
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