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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker Lead Adaptor
510(k) Number K852253
Device Name 329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR
Applicant
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Applicant Contact BETTY HERNANDEZ
Correspondent
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Correspondent Contact BETTY HERNANDEZ
Regulation Number870.3620
Classification Product Code
DTD  
Date Received05/24/1985
Decision Date 07/29/1985
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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