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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Chemical
510(k) Number K140464
Device Name STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER
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 Number880.6860
Classification Product Code
MLR  
Date Received02/24/2014
Decision Date 10/31/2014
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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