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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microtome, Accessories
510(k) Number K863616
Device Name KNIFE MAKER
Applicant
Surgipath Medical Industries, Inc.
P.O. Box 769
Grayslake,  IL  60030
Applicant Contact URBAN, HT(ASCP)
Correspondent
Surgipath Medical Industries, Inc.
P.O. Box 769
Grayslake,  IL  60030
Correspondent Contact URBAN, HT(ASCP)
Regulation Number864.3010
Classification Product Code
IDL  
Date Received09/16/1986
Decision Date 09/25/1986
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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