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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Laryngoscope, Endoscope
510(k) Number K003222
Device Name MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
Applicant
COMPUTER MOTION, INC.
130 CREMONA DR., SUITE B
GOLETA,  CA  93117
Applicant Contact DAVID U THOMAS
Correspondent
COMPUTER MOTION, INC.
130 CREMONA DR., SUITE B
GOLETA,  CA  93117
Correspondent Contact DAVID U THOMAS
Regulation Number876.1500
Classification Product Code
GCI  
Date Received10/16/2000
Decision Date 11/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
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