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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 K820783
Device Name CASTLE MICROCOMPUTER STERILIZER CONTROL
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 Number880.6860
Classification Product Code
FLF  
Date Received03/23/1982
Decision Date 04/15/1982
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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