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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K002915
Device Name FLEXIBLE OCCLUSION SYSTEM
Applicant
Applied Medical
22872 Avenida Empresa
Rancho Santa,  CA  92688
Applicant Contact ANIL BHALANI
Correspondent
Applied Medical
22872 Avenida Empresa
Rancho Santa,  CA  92688
Correspondent Contact ANIL BHALANI
Regulation Number870.4450
Classification Product Code
DXC  
Date Received09/18/2000
Decision Date 01/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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