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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, pacemaker, temporary
510(k) Number K190716
Device Name Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
1851 East Deere Ave.
santa ana,  CA  92705
Applicant Contact joven almazan
1851 East Deere Ave.
santa ana,  CA  92705
Correspondent Contact joven almazan
Regulation Number870.3680
Classification Product Code
Date Received03/19/2019
Decision Date 08/08/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No