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FDA 510(k) Application Details - K080881
Device Classification Name
Catheter, Urological
More FDA Info for this Device
510(K) Number
K080881
Device Name
Catheter, Urological
Applicant
CURE MEDICAL LLC.
29442 POINTE ROYAL
LAGUNA NIGUEL, CA 92677 US
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Contact
James Smith
Other 510(k) Applications for this Contact
Regulation Number
876.5130
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Classification Product Code
KOD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/2008
Decision Date
06/11/2008
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
Y
Expedited Review
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