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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 K802228
Device Name BIOLOGICAL INDICATOR - KEMMED & BIOSURE
Applicant
Kem Medical Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Kem Medical Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.2800
Classification Product Code
FRC  
Date Received09/10/1980
Decision Date 12/09/1980
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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