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FDA 510(k) Application Details - K123751
Device Classification Name
Catheter, Straight
More FDA Info for this Device
510(K) Number
K123751
Device Name
Catheter, Straight
Applicant
WELLSPECT HEALTHCARE
12264 EL CAMINO REAL
SUITE 400
SAN DIEGO, CA 92130 US
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Contact
Allison C Komiyama
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/06/2012
Decision Date
02/28/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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