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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name container, sharps
510(k) Number K123807
Device Name SHARPSCAN
Original Applicant
MEDICAL ENGINEERING DEVELOPMENT SOLUTIONS, INC.
11060 irma drive
northglenn,  CO  80233
Original Contact tim coressel
Regulation Number880.5570
Classification Product Code
MMK  
Date Received12/11/2012
Decision Date 07/23/2013
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
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