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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 K900982
Device Name E-CLIP
Applicant
Joel Cohen & Esther R. Cohen
1020 NW 99th Ave.
Plantation,  FL  33322
Applicant Contact JOEL COHEN
Correspondent
Joel Cohen & Esther R. Cohen
1020 NW 99th Ave.
Plantation,  FL  33322
Correspondent Contact JOEL COHEN
Regulation Number870.3680
Classification Product Code
LDF  
Date Received03/02/1990
Decision Date 04/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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