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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 K910722
Device Name 450CM GUIDE WIRE FOR G.I. USE
Applicant
Terumo Corp.
2100 Cottontail Ln.
Somerset,  NJ  08873
Applicant Contact GEORGE MOMODA
Correspondent
Terumo Corp.
2100 Cottontail Ln.
Somerset,  NJ  08873
Correspondent Contact GEORGE MOMODA
Regulation Number876.1500
Classification Product Code
OCY  
Date Received02/20/1991
Decision Date 03/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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