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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, neurovascular embolization
510(k) Number K964021
Device Name INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
Applicant
BAXTER EDWARDS
17221 RED HILL AVE.
IRVINE,  CA  92714 -5686
Applicant Contact PAULA A TORRIANNI
Correspondent
BAXTER EDWARDS
17221 RED HILL AVE.
IRVINE,  CA  92714 -5686
Correspondent Contact PAULA A TORRIANNI
Regulation Number882.5950
Classification Product Code
HCG  
Date Received10/07/1996
Decision Date 03/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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