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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 K915188
Device Name MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD
Applicant
Cook Pacemaker Corp.
P.O. Box 529
Leechburg,  PA  15656
Applicant Contact RICHARD E SHIREY
Correspondent
Cook Pacemaker Corp.
P.O. Box 529
Leechburg,  PA  15656
Correspondent Contact RICHARD E SHIREY
Regulation Number870.3680
Classification Product Code
DTB  
Date Received11/18/1991
Decision Date 09/11/1992
Decision SE - Postmarket Surveillance Required (SESP)
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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