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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K011264
Device Name MESH URETERAL STENT
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 Number876.4620
Classification Product Code
FAD  
Date Received04/25/2001
Decision Date 07/17/2001
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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