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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name marker, radiographic, implantable
510(k) Number K121964
Models MK-1011, MK-1031, MK-1101
Device Name MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
Original Applicant
AUGMENIX , INC.
204 second avenue
lower level
waltham,  MA  02451
Original Contact eric ankerud
Regulation Number878.4300
Classification Product Code
NEU  
Date Received07/05/2012
Decision Date 01/23/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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