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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Catheter
510(k) Number K940198
Device Name L-CATH CONNECTOR ASSEMBLY
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 Number878.4200
Classification Product Code
GCD  
Date Received01/13/1994
Decision Date 12/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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