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FDA 510(k) Application Details - K051541
Device Classification Name
Colonoscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K051541
Device Name
Colonoscope And Accessories, Flexible/Rigid
Applicant
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
Other 510(k) Applications for this Company
Contact
LAURA STORMS-TYLER
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FDF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/10/2005
Decision Date
07/01/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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