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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K193279
Device Name Comet II Pressure Guidewire
Applicant
Boston Scientific Corporation
Three Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact Kimberly Berg
Correspondent
Boston Scientific Corporation
Three Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact Kimberly Berg
Regulation Number870.2870
Classification Product Code
DXO  
Date Received11/27/2019
Decision Date 12/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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