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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 K915008
Device Name PERMANENT PACING PAD, MODIFICATION
Applicant
Oscor Medical Corp.
3816 Desoto Blvd.
P.O. Box 459
Palm Harbor,  FL  34683
Applicant Contact DEN NIEUWENHOF
Correspondent
Oscor Medical Corp.
3816 Desoto Blvd.
P.O. Box 459
Palm Harbor,  FL  34683
Correspondent Contact DEN NIEUWENHOF
Regulation Number870.3680
Classification Product Code
DTB  
Date Received11/04/1991
Decision Date 01/27/1992
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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