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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K022357
Device Name TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
Applicant
Boston Scientific, Target
47900 Bayside Pkwy.
Freemont,  CA  94538
Applicant Contact GEORGE J PRENDERGAST
Correspondent
Boston Scientific, Target
47900 Bayside Pkwy.
Freemont,  CA  94538
Correspondent Contact GEORGE J PRENDERGAST
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/19/2002
Decision Date 10/16/2002
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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