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FDA 510(k) Application Details - K132500
Device Classification Name
Catheter, Straight
More FDA Info for this Device
510(K) Number
K132500
Device Name
Catheter, Straight
Applicant
CURE MEDICAL LLC.
257 GARNET GARDEN STREET
HENDERSON, NV 89015 US
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Contact
JOHN BEASLEY
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
08/09/2013
Decision Date
12/23/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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