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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Knife, Surgical
510(k) Number K863549
Device Name REUSABLE/DISPOSABLE AUTOPSY KNIFE SET
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 Number878.4800
Classification Product Code
EMF  
Date Received09/12/1986
Decision Date 09/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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