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FDA 510(k) Application Details - K031382
Device Classification Name
Laparoscope, General & Plastic Surgery
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510(K) Number
K031382
Device Name
Laparoscope, General & Plastic Surgery
Applicant
COMPUTER MOTION, INC.
130 CREMONA DR., SUITE B
GOLETA, CA 93117 US
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Contact
KEITH LOWREY
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
GCJ
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More FDA Info for this Product Code
Date Received
05/01/2003
Decision Date
06/30/2003
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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