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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
Model 400272, 420274, 400275, 420275, 400272, 400173, 420173, 400174, 420174, 400169
Device Name 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
Original Applicant
INTUITIVE SURGICAL, INC.
950 kifer rd.
sunnyvale,  CA  94086 5206
Original Contact kim t servance
Regulation Number876.1500
Classification Product Code
NAY  
Date Received09/06/2011
Decision Date 09/29/2011
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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