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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K942103
Device Name L-CATH CATHETER SYSTEM - PORT L-CATH
Applicant
Luther Medical Products, Inc.
14332 Chambers Rd.
Tustin,  CA  92780
Applicant Contact BARBARA C LUTHER
Correspondent
Luther Medical Products, Inc.
14332 Chambers Rd.
Tustin,  CA  92780
Correspondent Contact BARBARA C LUTHER
Regulation Number880.5965
Classification Product Code
LJT  
Date Received05/02/1994
Decision Date 07/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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