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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Dilator, Catheter, Ureteral
510(k) Number K043254
Device Name PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH
Applicant
ONSET MEDICAL CORPORATION
27001 LA PAZ SUITE 312
MISSION VIEJO,  CA  92691
Applicant Contact ALBERT REGO
Correspondent
ONSET MEDICAL CORPORATION
27001 LA PAZ SUITE 312
MISSION VIEJO,  CA  92691
Correspondent Contact ALBERT REGO
Regulation Number876.5470
Classification Product Code
EZN  
Date Received11/24/2004
Decision Date 02/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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