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FDA 510(k) Application Details - K022270
Device Classification Name
Endoscopic Central Control Unit
More FDA Info for this Device
510(K) Number
K022270
Device Name
Endoscopic Central Control Unit
Applicant
OLYMPUS OPTICAL CO., LTD.
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
ODA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/15/2002
Decision Date
08/14/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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