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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 S. Redwood Rd. #102
North Salt Lake,  UT  84054
Applicant Contact DIXON FORD
Correspondent
Lazarus Medical Innovations, Inc.
Univ. Of Utah Research Park
40 S. 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
Predetermined Change
Control Plan Authorized		 No
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