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510(k) K123170

VARI-PASS VARIABLE LENGTH ACCESS SHEATH by Olympus Surgical Technologies America — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2013
Date Received
October 9, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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