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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 K850622
Device Name OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR
Applicant
Oscor Medical Corp.
Kaye, Scholer, Fierman, Hays &
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact ALLEN M FOX
Correspondent
Oscor Medical Corp.
Kaye, Scholer, Fierman, Hays &
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact ALLEN M FOX
Regulation Number870.3680
Classification Product Code
LDF  
Date Received02/19/1985
Decision Date 04/10/1985
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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