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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name septostomy catheter, reprocessed
510(k) Number K200060
Device Name Reprocessed NRG Transseptal Needle
Applicant
Innovative Health, LLC.
1435 North Hayden Road, Suite 100
Scottsdale,  AZ  85257
Applicant Contact Rick Ferreira
Correspondent
Innovative Health, LLC.
1435 North Hayden Road, Suite 100
Scottsdale,  AZ  85257
Correspondent Contact Christina Fleming
Regulation Number870.5175
Classification Product Code
QLZ  
Date Received01/13/2020
Decision Date 07/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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