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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Pasteurization, Hot Water
510(k) Number K860263
Device Name CASTLE 7538 FLOOR LOADING WASHER
Applicant
Castle Co.
C/O Nixon,Hargrave,Devan,Doyle
One Thomas Cir., Suite 800
Washington,  DC  20005
Applicant Contact STEPHEN KURZMAN
Correspondent
Castle Co.
C/O Nixon,Hargrave,Devan,Doyle
One Thomas Cir., Suite 800
Washington,  DC  20005
Correspondent Contact STEPHEN KURZMAN
Regulation Number880.6991
Classification Product Code
LDS  
Date Received01/27/1986
Decision Date 03/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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