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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 K884806
Device Name LUMED EXPANDO-CATH, ACTIV
Applicant
LUTHER MEDICAL PRODUCTS, INC.
14332 CHAMBERS RD.
TUSTIN,  CA  92780 -6912
Applicant Contact RONALD B LUTHER
Correspondent
LUTHER MEDICAL PRODUCTS, INC.
14332 CHAMBERS RD.
TUSTIN,  CA  92780 -6912
Correspondent Contact RONALD B LUTHER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/17/1988
Decision Date 02/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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