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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 K964107
Device Name OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR
Applicant
Oscor Medical Corp.
3816 Desoto Blvd.
P.O. Box 459
Palm Harbor,  FL  34683
Applicant Contact DAVID M LEE
Correspondent
Oscor Medical Corp.
3816 Desoto Blvd.
P.O. Box 459
Palm Harbor,  FL  34683
Correspondent Contact DAVID M LEE
Regulation Number870.3680
Classification Product Code
DTB  
Date Received10/15/1996
Decision Date 04/01/1997
Decision SE SUBJECT TO TRAKING & PMS (PT)
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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