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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 K770372
Device Name STERILIZER, STEAM, CASTLE 3000
Applicant
Castle Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Castle Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6880
Classification Product Code
FLE  
Date Received02/25/1977
Decision Date 04/05/1977
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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