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FDA 510(k) Application Details - K122505
Device Classification Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
More FDA Info for this Device
510(K) Number
K122505
Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
REGULATORY AFFAIRS & QUALITY ASSURANCE
3500 CORPORATE PARKWAY
CENTER VALLEY, PA 18034-0610 US
Other 510(k) Applications for this Company
Contact
SHERI MUSGNUNG
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
KNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/16/2012
Decision Date
04/11/2013
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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