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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 K854128
Device Name OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE
Applicant
Oscor Medical Corp.
2311 Us Alt. 19n.
P.O. Box 459
Palm Harbor,  FL  33563
Applicant Contact DE GRAAD
Correspondent
Oscor Medical Corp.
2311 Us Alt. 19n.
P.O. Box 459
Palm Harbor,  FL  33563
Correspondent Contact DE GRAAD
Regulation Number870.3680
Classification Product Code
DTB  
Date Received10/09/1985
Decision Date 02/26/1986
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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