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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fab, Rhodamine, Antigen, Antiserum, Control
510(k) Number K013866
Device Name CONVOY ADVANCED DELIVERY SHEATH KIT
Applicant
Boston Scientific
2710 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact ANDREA L RUTH
Correspondent
Boston Scientific
2710 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact ANDREA L RUTH
Regulation Number866.5520
Classification Product Code
DBY  
Date Received11/21/2001
Decision Date 12/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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