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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Permanent Pacemaker Electrode
510(k) Number K852446
Device Name ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP
Applicant
DIAG CORP.
14901 DEVEAU PLACE
MINNETONKA,  MN  55345 -2126
Applicant Contact LAWRENCE M KANE
Correspondent
DIAG CORP.
14901 DEVEAU PLACE
MINNETONKA,  MN  55345 -2126
Correspondent Contact LAWRENCE M KANE
Regulation Number870.3680
Classification Product Code
DTB  
Date Received06/10/1985
Decision Date 09/17/1985
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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