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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cabinet, Ethylene-Oxide Gas Aerator
510(k) Number K781484
Device Name CASTLE MODEL 3146 GAS AERATOR
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 Number880.6100
Classification Product Code
FLI  
Date Received08/28/1978
Decision Date 10/27/1978
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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