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FDA 510(k) Application Details - K133148
Device Classification Name
Endoscopic Injection Needle, Gastroenterology-Urology
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510(K) Number
K133148
Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Applicant
CARBON MEDICAL TECHNOLOGIES, INC.
1290 HAMMOND RD.
ST. PAUL, MN 55110 US
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Contact
ANDREW J ADAMS
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Regulation Number
876.1500
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Classification Product Code
FBK
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More FDA Info for this Product Code
Date Received
10/17/2013
Decision Date
05/13/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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