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510(k) K021179

DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A by Olympus Optical Co., Ltd. — Product Code OCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2002
Date Received
April 15, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Guidewire, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.

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