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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 K990775
Device Name URETERAL ACCESS SHEATH SET
Applicant
Applied Medical Resources
26051 Merit Circle
Bldg. 104
Launa Hills,  CA  92653
Applicant Contact ANIL BHALANI
Correspondent
Applied Medical Resources
26051 Merit Circle
Bldg. 104
Launa Hills,  CA  92653
Correspondent Contact ANIL BHALANI
Regulation Number876.1500
Classification Product Code
FED  
Date Received03/09/1999
Decision Date 04/21/1999
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
Predetermined Change
Control Plan Authorized		 No
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