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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 K872972
Device Name TEMPORARY PACEMAKER ELECTRODE
Applicant
Oscor Medical Corp.
2311 Us Alt. 19n.
P.O. Box 459
Palm Harbor,  FL  33563
Applicant Contact BRIAN K CORNISH
Correspondent
Oscor Medical Corp.
2311 Us Alt. 19n.
P.O. Box 459
Palm Harbor,  FL  33563
Correspondent Contact BRIAN K CORNISH
Regulation Number870.3680
Classification Product Code
LDF  
Date Received07/29/1987
Decision Date 12/03/1987
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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