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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 K141238
Device Name STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR
Applicant
Sterilucent, Inc.
1400 Marshall St., NE
Minneapolis,  MN  55413
Applicant Contact PETER KALKBRENNER
Correspondent
Sterilucent, Inc.
1400 Marshall St., NE
Minneapolis,  MN  55413
Correspondent Contact PETER KALKBRENNER
Regulation Number880.2800
Classification Product Code
FRC  
Date Received05/13/2014
Decision Date 11/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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