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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 K823446
Device Name PRODUCTS IMPLANTABLE PACING LEAD,TINED
Applicant
Oscor, Inc.
3816 Desoto Blvd.
Palm Harbor,  FL  34683
Correspondent
Oscor, Inc.
3816 Desoto Blvd.
Palm Harbor,  FL  34683
Regulation Number870.3680
Classification Product Code
DTB  
Date Received11/16/1982
Decision Date 12/03/1982
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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