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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 K061009
Device Name PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
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 Received04/12/2006
Decision Date 05/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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