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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K884866
Device Name TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1
Applicant
Oscor Medical Corp.
3816 Desoto Blvd.
P.O. Box 459
Palm Harbor,  FL  34683
Applicant Contact DE GRAAD
Correspondent
Oscor Medical Corp.
3816 Desoto Blvd.
P.O. Box 459
Palm Harbor,  FL  34683
Correspondent Contact DE GRAAD
Regulation Number870.3680
Classification Product Code
LDF  
Date Received11/21/1988
Decision Date 03/22/1989
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
Recalls CDRH Recalls
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