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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K973639
Device Name ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.
Applicant
J-Lloyd Medical, Inc.
415 Commerce Lane, Suite 7
West Berlin,  NJ  08091
Applicant Contact JAMES L SKAGGS
Correspondent
J-Lloyd Medical, Inc.
415 Commerce Lane, Suite 7
West Berlin,  NJ  08091
Correspondent Contact JAMES L SKAGGS
Regulation Number870.1220
Classification Product Code
DRF  
Date Received09/24/1997
Decision Date 04/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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