FDA 510(k) Application Details - K041984

Device Classification Name Sterilant, Medical Devices

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510(K) Number K041984
Device Name Sterilant, Medical Devices
Applicant BEST SANITIZERS, INC.
14605 28TH AVENUE NORTH
MINNEAPOLIS, MN 55428 US
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Contact RICHARD M ORMSBEE
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Regulation Number 880.6885

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Classification Product Code MED
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Date Received 07/23/2004
Decision Date 05/11/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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