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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K844277
Device Name OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR
Applicant
OMIKRON SCIENTIFIC, LTD.
KIRYAT WEIZMANN
P.O.B. 2012, REHOVOT 76120
ISRAEL,  IL
Applicant Contact SANDORD BROWN
Correspondent
OMIKRON SCIENTIFIC, LTD.
KIRYAT WEIZMANN
P.O.B. 2012, REHOVOT 76120
ISRAEL,  IL
Correspondent Contact SANDORD BROWN
Regulation Number870.1435
Classification Product Code
DXG  
Date Received11/05/1984
Decision Date 02/15/1985
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
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