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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K770953
Device Name MONITOR, AERATION, TEC-TEST
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 Number880.2800
Classification Product Code
FRC  
Date Received05/25/1977
Decision Date 07/14/1977
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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