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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 K905182
Device Name OSCOR MEDICAL CORP. PERMANENT PACING PAD
Applicant
Oscor Medical Corp.
3816 Desoto Blvd.
P.O. Box 459
Palm Harbor,  FL  34683
Applicant Contact RONALD NIEUWENHOF
Correspondent
Oscor Medical Corp.
3816 Desoto Blvd.
P.O. Box 459
Palm Harbor,  FL  34683
Correspondent Contact RONALD NIEUWENHOF
Regulation Number870.3680
Classification Product Code
DTB  
Date Received11/19/1990
Decision Date 05/07/1991
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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