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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 K113015
Device Name ALDAHOL V HIGH LEVEL DISINFECTANT
Applicant
MICROCHEM LABORATORIES, INC.
1107-c south airport circle
euless,  TX  76040
Contact norman miner
Regulation Number880.6885
Classification Product Code
MED  
Date Received10/11/2011
Decision Date 01/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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