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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K912788
Device Name CURAY SUPPORT
Applicant
Scientific Pharmaceuticals, Inc.
321 Producer Way
Pomona,  CA  91768
Applicant Contact DR.JAN A.ORLOWSKI
Correspondent
Scientific Pharmaceuticals, Inc.
321 Producer Way
Pomona,  CA  91768
Correspondent Contact DR.JAN A.ORLOWSKI
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/24/1991
Decision Date 08/23/1991
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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