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FDA 510(k) Application Details - K073484
Device Classification Name
Endoscope Channel Accessory
More FDA Info for this Device
510(K) Number
K073484
Device Name
Endoscope Channel Accessory
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
Other 510(k) Applications for this Company
Contact
RENEE L ROWE
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
ODC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/11/2007
Decision Date
03/10/2008
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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