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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K013555
Device Name SCI-PHARM POST SECURE
Applicant
Scientific Pharmaceuticals, Inc.
3221 Producer Way
Pomona,  CA  91768
Applicant Contact JAN A ORLOWSKI
Correspondent
Scientific Pharmaceuticals, Inc.
3221 Producer Way
Pomona,  CA  91768
Correspondent Contact JAN A ORLOWSKI
Regulation Number872.3275
Classification Product Code
EMA  
Date Received10/25/2001
Decision Date 01/23/2002
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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