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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Ethylene-Oxide Gas
510(k) Number K792660
Device Name 1500 EO EXHAUST HOOD
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 Number880.6860
Classification Product Code
FLF  
Date Received12/27/1979
Decision Date 01/29/1980
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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