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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 K961893
Device Name DURAFLOR
Applicant
PHARMASCIENCE, INC.
8235 ROANOKE CT.
SEVERN,  MD  21144
Applicant Contact LOUIS HLAVINKA
Correspondent
PHARMASCIENCE, INC.
8235 ROANOKE CT.
SEVERN,  MD  21144
Correspondent Contact LOUIS HLAVINKA
Regulation Number872.3260
Classification Product Code
LBH  
Date Received05/16/1996
Decision Date 08/14/1996
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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