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FDA 510(k) Application Details - K051905
Device Classification Name
Endoscopic Injection Needle, Gastroenterology-Urology
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510(K) Number
K051905
Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Applicant
UROPLASTY, INC.
2718 SUMMER ST. NE
MINNEAPOLIS, MN 55413-2820 US
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Contact
MICHAEL MORRELL
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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
07/14/2005
Decision Date
08/29/2005
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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