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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 K030488
Device Name FLUORILAQ
Applicant
PASCAL CO., INC.
2929 N.E. NORTHUP WAY
BELLEVUE,  WA  98004
Applicant Contact VINCENT M TENTARELLI
Correspondent
PASCAL CO., INC.
2929 N.E. NORTHUP WAY
BELLEVUE,  WA  98004
Correspondent Contact VINCENT M TENTARELLI
Regulation Number872.3260
Classification Product Code
LBH  
Date Received02/14/2003
Decision Date 05/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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