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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 K092789
Device Name VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Applicant Contact CHRISTINA THOMAS
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Correspondent Contact CHRISTINA THOMAS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/10/2009
Decision Date 05/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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