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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 K861270
Device Name BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED.
Applicant
Surgipath Medical Industries, Inc.
P.O. Box 769
Grayslake,  IL  60030
Applicant Contact HT (ASCP)
Correspondent
Surgipath Medical Industries, Inc.
P.O. Box 769
Grayslake,  IL  60030
Correspondent Contact HT (ASCP)
Regulation Number864.4010
Classification Product Code
KEO  
Date Received04/04/1986
Decision Date 04/11/1986
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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