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FDA 510(k) Application Details - K043254
Device Classification Name
Dilator, Catheter, Ureteral
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510(K) Number
K043254
Device Name
Dilator, Catheter, Ureteral
Applicant
ONSET MEDICAL CORPORATION
27001 LA PAZ SUITE 312
MISSION VIEJO, CA 92691 US
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Contact
ALBERT REGO
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Regulation Number
876.5470
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Classification Product Code
EZN
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More FDA Info for this Product Code
Date Received
11/24/2004
Decision Date
02/10/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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