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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Guidewire, Gastroenterology-Urology
510(k) Number K021179
Device Name DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A
Applicant
Olympus Optical Co., Ltd.
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus Optical Co., Ltd.
Two Corporate Center Dr.
Melville,  NY  11747
Correspondent Contact LAURA STORMS-TYLER
Regulation Number876.1500
Classification Product Code
OCY  
Date Received04/15/2002
Decision Date 07/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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