FDA 510(k) Application Details - K080155

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K080155
Device Name Laparoscope, General & Plastic Surgery
Applicant INTUITIVE SURGICAL, INC.
950 KIFER RD.
SUNNYVALE, CA 94086-5206 US
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Contact MICHAEL H YRAMATEGUI
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 01/23/2008
Decision Date 03/06/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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