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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 K021152
Device Name ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES
Applicant
COMPUTER MOTION, INC.
130-B CREMONA DR.
GOLETA,  CA  93117
Applicant Contact DAVID MUNJAL
Correspondent
COMPUTER MOTION, INC.
130-B CREMONA DR.
GOLETA,  CA  93117
Correspondent Contact DAVID MUNJAL
Regulation Number876.1500
Classification Product Code
NAY  
Date Received04/10/2002
Decision Date 09/24/2002
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
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