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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K003938
Device Name TRAK BACK II
Applicant
JOMED, INC.
1700 ROCKVILLE PIKE
SUITE 400
ROCKVILLE,  MD  20852
Applicant Contact CHRISTINA KICHULA
Correspondent
JOMED, INC.
1700 ROCKVILLE PIKE
SUITE 400
ROCKVILLE,  MD  20852
Correspondent Contact CHRISTINA KICHULA
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/20/2000
Decision Date 01/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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