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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 K022897
Device Name MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
Applicant
Computer Motion, Inc.
130 Cremona Dr., Suite B
Goleta,  CA  93117
Applicant Contact CATHY STUPAK
Correspondent
Computer Motion, Inc.
130 Cremona Dr., Suite B
Goleta,  CA  93117
Correspondent Contact CATHY STUPAK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/03/2002
Decision Date 10/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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