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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic injection needle, gastroenterology-urology
510(k) Number K172227
Device Name Endoscopic Injection Needle
Applicant
Carbon Medical Technologies, Inc.
1290 Hammond Road
Saint Paul,  MN  55110 -5867
Applicant Contact Andrew J. Adams
Correspondent
Carbon Medical Technologies, Inc.
1290 Hammond Road
Saint Paul,  MN  55110 -5867
Correspondent Contact Andrew J. Adams
Regulation Number876.1500
Classification Product Code
FBK  
Date Received07/25/2017
Decision Date 08/23/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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