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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Formulations, Paraffin, All
510(k) Number K893772
Device Name TISSUE EMBEDDING MEDIUM
Applicant
Stephens Scientific
7 Astro Pl., P.O. Box 1116
Denville,  NJ  07834
Applicant Contact R SAVUTO
Correspondent
Stephens Scientific
7 Astro Pl., P.O. Box 1116
Denville,  NJ  07834
Correspondent Contact R SAVUTO
Regulation Number864.4010
Classification Product Code
KEO  
Date Received05/22/1989
Decision Date 06/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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