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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, diagnostic
510(k) Number K913871
Device Name FLOSWITCH(R) HP
Applicant
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Applicant Contact PAMELA L CADORETTE
Correspondent
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Correspondent Contact PAMELA L CADORETTE
Regulation Number870.1200
Classification Product Code
DQO  
Date Received08/28/1991
Decision Date 11/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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