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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K142937
Device Name Endoscope Sterilization Tray
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
SUNNYVALE,  CA  94086 -5206
Applicant Contact Nadine Nasr
Correspondent
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
SUNNYVALE,  CA  94086 -5206
Correspondent Contact Nadine Nasr
Regulation Number880.6850
Classification Product Code
KCT  
Date Received10/09/2014
Decision Date 02/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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