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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 K972699
Device Name AESOP 3000 SYSTEM AND ACCESSORIES
Applicant
COMPUTER MOTION, INC.
130-B CREMONA DR.
GOLETA,  CA  93117
Applicant Contact DOUGLAS P BUESCHEL
Correspondent
COMPUTER MOTION, INC.
130-B CREMONA DR.
GOLETA,  CA  93117
Correspondent Contact DOUGLAS P BUESCHEL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/18/1997
Decision Date 12/19/1997
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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