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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 K983305
Device Name SCI-PHARM DESENSITIZING VARNISH
Applicant
Scientific Pharmaceuticals, Inc.
3221 Producer Way
Pomona,  CA  91768 -3916
Applicant Contact JAN A ORLOWSKI
Correspondent
Scientific Pharmaceuticals, Inc.
3221 Producer Way
Pomona,  CA  91768 -3916
Correspondent Contact JAN A ORLOWSKI
Regulation Number872.3260
Classification Product Code
LBH  
Date Received09/21/1998
Decision Date 12/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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