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FDA 510(k) Application Details - K021036
Device Classification Name
System,Surgical,Computer Controlled Instrument
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510(K) Number
K021036
Device Name
System,Surgical,Computer Controlled Instrument
Applicant
INTUITIVE SURGICAL, INC.
950 KIFER RD.
SUNNYVALE, CA 94086-5206 US
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DAVID CASAL
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Regulation Number
876.1500
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Classification Product Code
NAY
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Date Received
04/01/2002
Decision Date
06/26/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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