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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 K955521
Device Name ALPHA-DENT COPAL CAVITY VARNISH
Applicant
WALLACE A. ERICKSON & CO.
1920 N. CLYBOURN AVE.
CHICAGO,  IL  60614
Applicant Contact ABNER T DE LA CRUZ
Correspondent
WALLACE A. ERICKSON & CO.
1920 N. CLYBOURN AVE.
CHICAGO,  IL  60614
Correspondent Contact ABNER T DE LA CRUZ
Regulation Number872.3260
Classification Product Code
LBH  
Date Received12/04/1995
Decision Date 01/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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