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FDA 510(k) Application Details - K122078
Device Classification Name
Catheter, Straight
More FDA Info for this Device
510(K) Number
K122078
Device Name
Catheter, Straight
Applicant
ASTRA TECH, INC.
11234 EL CAMINO REAL, STE 200
SAN DIEGO, CA 92130 US
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Contact
Allison C Komiyama
Other 510(k) Applications for this Contact
Regulation Number
876.5130
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Classification Product Code
EZD
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More FDA Info for this Product Code
Date Received
07/16/2012
Decision Date
10/31/2012
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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