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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 K965071
Device Name DETACHABLE SLICONE 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 Received12/19/1996
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
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