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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, retention type, balloon
510(k) Number K010006
Device Name DRAINAGE CATHETER OR FOLEY 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
EZL  
Date Received01/02/2001
Decision Date 07/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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