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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, Programmable
510(k) Number K881770
Device Name EPICARDIA LE/FD
Applicant
MEDICOMP, INC.
7845 ELLIS RD.
WEST MELBOURNE,  FL  32904
Applicant Contact JOE RIFFE
Correspondent
MEDICOMP, INC.
7845 ELLIS RD.
WEST MELBOURNE,  FL  32904
Correspondent Contact JOE RIFFE
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/26/1988
Decision Date 05/31/1988
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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