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FDA 510(k) Application Details - K090796
Device Classification Name
Forceps, Biopsy, Electric
More FDA Info for this Device
510(K) Number
K090796
Device Name
Forceps, Biopsy, Electric
Applicant
ENDO-THERAPEUTICS, INC.
15251 ROOSEVELT BLVD.
SUITE 204
CLEARWATER, FL 33760 US
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Contact
MARK R WADDELL
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
KGE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/24/2009
Decision Date
11/25/2009
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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