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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 K792558
Device Name CONTAINER SYSTEM
Applicant
Aesculap Instruments Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Aesculap Instruments Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6880
Classification Product Code
FLE  
Date Received12/12/1979
Decision Date 12/27/1979
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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