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FDA 510(k) Application Details - K011151
Device Classification Name
Gastroscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K011151
Device Name
Gastroscope And Accessories, Flexible/Rigid
Applicant
THE OLYMPUS OPTICAL CO.
ENDOSCOPE DIVISION
TWO CORPORATE CENTER DRIVE
MELVILLE, NY 11747-3157 US
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LAURA STORMS-TYLER
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FDS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/16/2001
Decision Date
05/15/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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