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FDA 510(k) Application Details - K102763
Device Classification Name
Endoscopic Central Control Unit
More FDA Info for this Device
510(K) Number
K102763
Device Name
Endoscopic Central Control Unit
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
CENTER VALLEY, PA 18034-0610 US
Other 510(k) Applications for this Company
Contact
STACY ABBATIELLO
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
09/24/2010
Decision Date
02/15/2011
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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