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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 K924968
Device Name L-CATH PEEL-AWAY CATHETER SYSTEM
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 Number880.5200
Classification Product Code
FOZ  
Date Received09/30/1992
Decision Date 05/21/1993
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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