FDA 510(k) Application Details - K980787

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K980787
Device Name Laparoscope, General & Plastic Surgery
Applicant COMPUTER MOTION, INC.
130 CREMONA DR., SUITE B
GOLETA, CA 93117 US
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Contact DOUGLAS P BUESCHEL
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 03/02/1998
Decision Date 07/13/1998
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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