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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, surgical, computer controlled instrument
510(k) Number K112584
Device Name 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
Applicant
INTUITIVE SURGICAL, INC.
950 KIFER RD.
SUNNYVALE,  CA  94086 -5206
Applicant Contact KIM T SERVANCE
Correspondent
INTUITIVE SURGICAL, INC.
950 KIFER RD.
SUNNYVALE,  CA  94086 -5206
Correspondent Contact KIM T SERVANCE
Regulation Number876.1500
Classification Product Code
NAY  
Date Received09/06/2011
Decision Date 09/29/2011
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
Recalls CDRH Recalls
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