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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K191999
Device Name Sterilucent VH2O2 Chemical Indicators
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
JOJ  
Date Received07/26/2019
Decision Date 10/21/2019
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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