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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Embolectomy
510(k) Number K974335
Device Name EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
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 Number870.5150
Classification Product Code
DXE  
Date Received11/18/1997
Decision Date 02/13/1998
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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