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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 K893763
Device Name MODELS 1113 AND 1114 PACEMAKER LEADS
Applicant
Possis Medical, Inc.
8325 10th Ave. N.
Minneapolis,  MN  55427
Applicant Contact J SCOTT
Correspondent
Possis Medical, Inc.
8325 10th Ave. N.
Minneapolis,  MN  55427
Correspondent Contact J SCOTT
Regulation Number870.3680
Classification Product Code
DTB  
Date Received05/19/1989
Decision Date 07/14/1989
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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