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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 K972623
Device Name LMI IRRIGATION CATHETER (IGR)
Applicant
Lucas Medical, Inc.
1751 S. Douglass Rd.
Anaheim,  CA  92806
Applicant Contact DANIEL LUCAS
Correspondent
Lucas Medical, Inc.
1751 S. Douglass Rd.
Anaheim,  CA  92806
Correspondent Contact DANIEL LUCAS
Regulation Number870.5150
Classification Product Code
DXE  
Date Received07/14/1997
Decision Date 11/19/1997
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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