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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 K813201
Device Name CASTLE #3241 GAS AERATOR
Applicant
Sybron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sybron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6100
Classification Product Code
FLI  
Date Received11/13/1981
Decision Date 12/31/1981
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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