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FDA 510(k) Application Details - K093106
Device Classification Name
Accessories, Cleaning, For Endoscope
More FDA Info for this Device
510(K) Number
K093106
Device Name
Accessories, Cleaning, For Endoscope
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
CENTER VALLEY, PA 18034-0610 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
FEB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2009
Decision Date
02/12/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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