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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 K823894
Device Name MODEL RZ PACEMAKER LEAD VARIOUS
Applicant
Dr. Ing. P. Osypka, GmbH
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dr. Ing. P. Osypka, GmbH
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.3680
Classification Product Code
DTB  
Date Received12/27/1982
Decision Date 04/30/1983
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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