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FDA 510(k) Application Details - K090980
Device Classification Name
Endoscope, Accessories, Narrow Band Spectrum
More FDA Info for this Device
510(K) Number
K090980
Device Name
Endoscope, Accessories, Narrow Band Spectrum
Applicant
OLYMPUS WINTER & IBE GMBH
3500 CORPORATE PKWAY
PO BOX 610
CENTER VALLEY, PA 18034-0610 US
Other 510(k) Applications for this Company
Contact
STACY A KUESNER
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
NWB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/07/2009
Decision Date
06/29/2009
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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