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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 K945068
Device Name OMEGA CARES SYSTEM
Applicant
J-F Medical Systems Intl., Inc.
2440 Lacy Ln., Suite 101
Carrollton,  TX  75006
Applicant Contact RICHARD A HAMER
Correspondent
J-F Medical Systems Intl., Inc.
2440 Lacy Ln., Suite 101
Carrollton,  TX  75006
Correspondent Contact RICHARD A HAMER
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/14/1994
Decision Date 01/25/1996
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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