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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 K864051
Device Name TUBULICID RED LABEL
Applicant
DENTAL DIMENSIONS SUPPLY CO.
1028 MCLEAN AVE.
WANTAGH,  NY  11793
Applicant Contact JERRY L BARTICK
Correspondent
DENTAL DIMENSIONS SUPPLY CO.
1028 MCLEAN AVE.
WANTAGH,  NY  11793
Correspondent Contact JERRY L BARTICK
Regulation Number872.3260
Classification Product Code
LBH  
Date Received10/16/1986
Decision Date 12/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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