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FDA 510(k) Application Details - K012977
Device Classification Name
Endoscopic Injection Needle, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K012977
Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Applicant
ENDO-THERAPEUTICS, INC.
1183 CEDAR ST.
SAFETY HARBOR, FL 34695-2908 US
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Contact
TODD ADKISSON
Other 510(k) Applications for this Contact
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
09/05/2001
Decision Date
11/02/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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