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FDA 510K (K023046) SST SALIVA SUPPORTING TABLETS
FDA 510K (K023046) SST SALIVA SUPPORTING TABLETS
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Device Classification Name Stains, Chemical Solution
510(k) Number K023046
Device Name SST SALIVA SUPPORTING TABLETS
Applicant SINCLAIR PHARMACEUTICALS, LTD.
Regulation Number 864.1850
Classification Product Code LED
Date Received 09/12/2002
Decision Date 12/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Total pages: 61
Fully redacted pages: 13
Content pages: 48
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