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FDA 510(k) Application Details - K082319
Device Classification Name
Endoscopic Injection Needle, Gastroenterology-Urology
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510(K) Number
K082319
Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
SPENCER, IN 47460 US
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Contact
CINDY FOOTE
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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
08/13/2008
Decision Date
09/25/2008
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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