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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
Device Name MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
Applicant
Augmenix, Inc.
204 Second Ave., Lower Level
Waltham,  MA  02451
Applicant Contact Eric Ankerud
Correspondent
Augmenix, Inc.
204 Second Ave., Lower Level
Waltham,  MA  02451
Correspondent Contact Eric Ankerud
Regulation Number878.4300
Classification Product Code
NEU  
Date Received07/05/2012
Decision Date 01/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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