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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, surgical, computer controlled instrument
510(k) Number K011281
Device Name INTUITIVE SURGICAL ULTRASONIC SHEARS
Applicant
INTUITIVE SURGICAL, INC.
1340 WEST MIDDLEFIELD RD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact MICHAEL YRAMATEGUI
Correspondent
INTUITIVE SURGICAL, INC.
1340 WEST MIDDLEFIELD RD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact MICHAEL YRAMATEGUI
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
LFL  
Date Received04/27/2001
Decision Date 07/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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