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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K870975
Device Name MODIFIED CASTLE POWERCLAVE
Applicant
Castle Co.
Suite 800
One Thomas Circle
Washington,  DC  20005
Applicant Contact KURZMAN, PC
Correspondent
Castle Co.
Suite 800
One Thomas Circle
Washington,  DC  20005
Correspondent Contact KURZMAN, PC
Regulation Number880.6880
Classification Product Code
FLE  
Date Received03/10/1987
Decision Date 04/17/1987
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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