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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 K011002
Device Name INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
Applicant
INTUITIVE SURGICAL, INC.
1340 WEST MIDDLEFIELD RD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact DAVID CASAL
Correspondent
INTUITIVE SURGICAL, INC.
1340 WEST MIDDLEFIELD RD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact DAVID CASAL
Regulation Number876.1500
Classification Product Code
NAY  
Date Received04/03/2001
Decision Date 05/30/2001
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
Predetermined Change
Control Plan Authorized		 No
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