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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K935404
Device Name FLOW DIRECTED THERMODILUTION BALLOON CATHETER
Applicant
J-Lloyd Medical, Inc.
415 Commerce Ln., Suite 6
West Berlin,  NJ  08091
Applicant Contact JAMES L SKAGGS, SR.
Correspondent
J-Lloyd Medical, Inc.
415 Commerce Ln., Suite 6
West Berlin,  NJ  08091
Correspondent Contact JAMES L SKAGGS, SR.
Regulation Number870.1240
Classification Product Code
DYG  
Date Received11/09/1993
Decision Date 05/03/1994
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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