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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name indicator, biological sterilization process
510(k) Number K122362
Device Name SMART-WELL INCUBATOR
Original Applicant
MESA LABORATORIES, INC.
12100 w. 6th avenue
lakewood,  CO  80228
Original Contact jole wilson
Regulation Number880.2800
Classification Product Code
FRC  
Date Received08/06/2012
Decision Date 03/26/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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