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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name trocar, reprocessed
510(k) Number K192998
Device Name Reprocessed BRK Transseptal Needle
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 Number870.1390
Classification Product Code
NMK  
Date Received10/28/2019
Decision Date 07/22/2020
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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