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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K010874
Device Name 6F MACH 1, MODEL 34356-XXX
Applicant
Boston Scientific Corp
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact TODD KORNMANN
Correspondent
Boston Scientific Corp
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact TODD KORNMANN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/23/2001
Decision Date 06/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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