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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
Applicant
MESA LABORATORIES, INC.
12100 W. 6TH AVENUE
LAKEWOOD,  CO  80228
Applicant Contact JOLE WILSON
Correspondent
MESA LABORATORIES, INC.
12100 W. 6TH AVENUE
LAKEWOOD,  CO  80228
Correspondent Contact JOLE WILSON
Regulation Number880.2800
Classification Product Code
FRC  
Date Received08/06/2012
Decision Date 03/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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