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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K152872
Device Name K2M Fenestrated Tap System
Applicant
K2m
751 Miller Dr. SE
Leesburg,  VA  20175
Applicant Contact NANCY GIEZEN
Correspondent
K2m
751 Miller Dr. SE
Leesburg,  VA  20175
Correspondent Contact NANCY GIEZEN
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
OAR  
Date Received09/30/2015
Decision Date 01/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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