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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 K870562
Device Name DAIG PACEMAKER LEAD ADAPTOR
Applicant
DAIG CORP.
14901 DEVEAU PLACE
MINNETONKA,  MN  55345 -2126
Applicant Contact J FLEISCHHACKER
Correspondent
DAIG CORP.
14901 DEVEAU PLACE
MINNETONKA,  MN  55345 -2126
Correspondent Contact J FLEISCHHACKER
Regulation Number870.3620
Classification Product Code
DTD  
Date Received02/10/1987
Decision Date 03/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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