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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter For Crossing Total Occlusions
510(k) Number K192211
Device Name SoundBite Console, SoundBite Active Wire 18
Applicant
Soundbite Medical Solution, Inc.
2300 Blvd. Alfred Nobel
Montreal,  CA H4S 2A4
Applicant Contact Marc Andre Cote
Correspondent
Soundbite Medical Solution, Inc.
2300 Blvd. Alfred Nobel
Montreal,  CA H4S 2A4
Correspondent Contact Marc Andre Cote
Regulation Number870.1250
Classification Product Code
PDU  
Date Received08/14/2019
Decision Date 01/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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