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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 K232261
Device Name TME Temporary Myocardial Electrode
Applicant
Osypka AG
Earl-H.-Wood St. 1
Rheinfelden,  DE 79618
Applicant Contact Nicola Osypka
Correspondent
Osypka AG
Earl-H.-Wood St. 1
Rheinfelden,  DE 79618
Correspondent Contact Nicola Osypka
Regulation Number870.3680
Classification Product Code
LDF  
Date Received07/31/2023
Decision Date 04/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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