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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 K022067
Device Name CONVOY ADVANCED DELIVERY SHEATH
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 Received06/25/2002
Decision Date 09/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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