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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 K982915
Device Name SCI-PHARM DFV 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 Received08/19/1998
Decision Date 02/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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