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FDA 510(k) Application Details - K060475
Device Classification Name
Endoscopic Contamination Prevention Sheath
More FDA Info for this Device
510(K) Number
K060475
Device Name
Endoscopic Contamination Prevention Sheath
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-9058 US
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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
ODB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/23/2006
Decision Date
03/17/2006
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
Y
Expedited Review
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