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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K924486
Device Name CARD GUARD, MODEL CG-9000
Applicant
Card Guard Scientific Survival , Ltd.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact JOHNATHAN S KAHAN
Correspondent
Card Guard Scientific Survival , Ltd.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact JOHNATHAN S KAHAN
Regulation Number870.2920
Classification Product Code
DXH  
Date Received09/03/1992
Decision Date 10/31/1994
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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