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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K040010
Device Name GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS
Applicant
Genesis Medical Interventional, Inc.
652 Bair Island Rd.
Suite 103
Redwood City,  CA  94063
Applicant Contact ANNE WORDEN
Correspondent
Genesis Medical Interventional, Inc.
652 Bair Island Rd.
Suite 103
Redwood City,  CA  94063
Correspondent Contact ANNE WORDEN
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received01/05/2004
Decision Date 07/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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