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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
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