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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, ureteral, gastro-urology
510(k) Number K020577
Device Name APPLIED URETERAL CATHETER
Applicant
APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact ANIL BHALANI
Correspondent
APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact ANIL BHALANI
Regulation Number876.5130
Classification Product Code
EYB  
Date Received02/21/2002
Decision Date 05/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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