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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 K862141
Device Name HISTOLOGY PARAFFIN
Applicant
Erie Scientific Co.
Portsmouth Industrial Park
Portsmouth,  NH  03801
Applicant Contact HENRY N WILLIAMS
Correspondent
Erie Scientific Co.
Portsmouth Industrial Park
Portsmouth,  NH  03801
Correspondent Contact HENRY N WILLIAMS
Regulation Number864.4010
Classification Product Code
KEO  
Date Received06/04/1986
Decision Date 06/13/1986
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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