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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cholangiography
510(k) Number K873471
Device Name LMI CHOLANGIOGRAM TRAY
Applicant
LAZARUS MEDICAL INNOVATIONS, INC.
UNIV. OF UTAH RESEARCH PARK
40 SOUTH REDWOOD RD. #102
NORTH SALT LAKE,  UT  84054
Applicant Contact DIXON FORD
Correspondent
LAZARUS MEDICAL INNOVATIONS, INC.
UNIV. OF UTAH RESEARCH PARK
40 SOUTH REDWOOD RD. #102
NORTH SALT LAKE,  UT  84054
Correspondent Contact DIXON FORD
Regulation Number878.4200
Classification Product Code
GBZ  
Date Received08/28/1987
Decision Date 10/23/1987
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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