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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, electrode recording, or probe, electrode recording
510(k) Number K183632
Device Name Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable
Applicant
Baylis Medical Company Inc.
2580 Matheson Blvd. E
Mississauga,  CA L4W 4J1
Applicant Contact Meghal Khakhar
Correspondent
Baylis Medical Company Inc.
2580 Matheson Blvd. E
Mississauga,  CA L4W 4J1
Correspondent Contact Meghal Khakhar
Regulation Number870.1220
Classification Product Code
DRF  
Date Received12/26/2018
Decision Date 06/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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