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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic access overtube, gastroenterology-urology
510(k) Number K030642
Device Name DEFLECTING URETERAL ACCESS SHEATH
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 Number876.1500
Classification Product Code
FED  
Date Received02/28/2003
Decision Date 05/23/2003
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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