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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, recording, electrode, reprocessed
510(k) Number K191170
Device Name Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter
Applicant
Innovative Health, LLC.
1435 North Hayden Road, Suite 100
scottsdale,  AZ  85257
Applicant Contact amanda babcock
Correspondent
Innovative Health, LLC.
1435 North Hayden Road, Suite 100
scottsdale,  AZ  85257
Correspondent Contact amanda babcock
Regulation Number870.1220
Classification Product Code
NLH  
Subsequent Product Code
DRF  
Date Received05/01/2019
Decision Date 10/30/2019
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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