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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K993292
Device Name BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER
Applicant
Boston Scientific, Target
47900 Bayside Pkwy.
Freemont,  CA  94538
Applicant Contact GOWAN LEE
Correspondent
Boston Scientific, Target
47900 Bayside Pkwy.
Freemont,  CA  94538
Correspondent Contact GOWAN LEE
Regulation Number870.4450
Classification Product Code
MJN  
Date Received10/01/1999
Decision Date 03/23/2000
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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