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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, Pasteurization, Hot Water
510(k) Number K810311
Device Name STERI-VERS
Applicant
The Hilrad Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The Hilrad Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6991
Classification Product Code
LDS  
Date Received02/05/1981
Decision Date 04/17/1981
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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