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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 K965001
Device Name INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR
Applicant
Intuitive Surgical, Inc.
1340 Middlefield Rd.
Mountain View,  CA  94304
Applicant Contact MICHAEL A DANIEL
Correspondent
Intuitive Surgical, Inc.
1340 Middlefield Rd.
Mountain View,  CA  94304
Correspondent Contact MICHAEL A DANIEL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/16/1996
Decision Date 07/31/1997
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
Predetermined Change
Control Plan Authorized		 No
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