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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K853348
Device Name L-CATH EXPANDO CATH
Applicant
Luther Medical Products, Inc.
1940 E. Occidental St.
Santa Ana,  CA  92705
Applicant Contact RONALD B LUTHER
Correspondent
Luther Medical Products, Inc.
1940 E. Occidental St.
Santa Ana,  CA  92705
Correspondent Contact RONALD B LUTHER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/12/1985
Decision Date 01/09/1986
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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