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FDA 510(k) Application Details - K123807
Device Classification Name
Container, Sharps
More FDA Info for this Device
510(K) Number
K123807
Device Name
Container, Sharps
Applicant
MEDICAL ENGINEERING DEVELOPMENT SOLUTIONS, INC.
11060 IRMA DRIVE
NORTHGLENN, CO 80233 US
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Contact
TIM CORESSEL
Other 510(k) Applications for this Contact
Regulation Number
880.5570
More FDA Info for this Regulation Number
Classification Product Code
MMK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/11/2012
Decision Date
07/23/2013
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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