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FDA 510(k) Application Details - K192877
Device Classification Name
System,Surgical,Computer Controlled Instrument
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510(K) Number
K192877
Device Name
System,Surgical,Computer Controlled Instrument
Applicant
TransEnterix, Inc.
635 Davis Drive, Suite 300
Morrisville, NC 27560 US
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Contact
Kaitlyn Alexander
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
NAY
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More FDA Info for this Product Code
Date Received
10/08/2019
Decision Date
11/22/2019
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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