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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 K862656
Device Name PACEMAKER LEAD ADAPTER
Applicant
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Applicant Contact DONNA L ROGERS
Correspondent
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Correspondent Contact DONNA L ROGERS
Regulation Number870.3620
Classification Product Code
DTD  
Date Received07/14/1986
Decision Date 07/30/1986
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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