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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Balloon, Detachable, For Neurovascular Occlusion
510(k) Number K964488
Device Name DETACHABLE SILICONE BALLOON (DSB)
Applicant
Target Therapeutics
47201 Lakeview Dr.
Freemont,  CA  94538 -6530
Applicant Contact LYNN K BELL
Correspondent
Target Therapeutics
47201 Lakeview Dr.
Freemont,  CA  94538 -6530
Correspondent Contact LYNN K BELL
Regulation Number882.5950
Classification Product Code
MZQ  
Date Received11/08/1996
Decision Date 04/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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