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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K031891
Device Name VIRTUOSAPH
Applicant
Terumo Cardiovascular Systems Corp.
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact KIM AVES
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact HEINZ JOERG STENEBERG
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/13/2003
Decision Date 07/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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