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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 K844089
Device Name CASTLE 7515 UTENSIL/GLASSWARE 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 Received10/22/1984
Decision Date 01/14/1985
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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