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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 K932046
Device Name LIFE-TELL T.S.S.
Applicant
Raco Products Co.
5504 State Rd.
Cleveland,  OH  44134
Applicant Contact GERALD J CAHILL
Correspondent
Raco Products Co.
5504 State Rd.
Cleveland,  OH  44134
Correspondent Contact GERALD J CAHILL
Regulation Number870.2920
Classification Product Code
DXH  
Date Received04/27/1993
Decision Date 08/29/1994
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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