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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilant, Medical Devices
510(k) Number K041984
Device Name ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
Applicant
Best Sanitizers, Inc.
14605 28th Ave. N.
Minneapolis,  MN  55428
Applicant Contact RICHARD M ORMSBEE
Correspondent
Best Sanitizers, Inc.
14605 28th Ave. N.
Minneapolis,  MN  55428
Correspondent Contact RICHARD M ORMSBEE
Regulation Number880.6885
Classification Product Code
MED  
Date Received07/23/2004
Decision Date 05/11/2005
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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