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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 -6912
Applicant Contact BARBARA C LUTHER
Correspondent
LUTHER MEDICAL PRODUCTS, INC.
14332 CHAMBERS RD.
TUSTIN,  CA  92780 -6912
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
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