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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 K924128
Device Name CHOLANGIOGRAPHY CATHETER
Applicant
Applied Medical Resources
26051 Merit Circle
Bldg. 104
Launa Hills,  CA  92653
Applicant Contact JO STEGWELL
Correspondent
Applied Medical Resources
26051 Merit Circle
Bldg. 104
Launa Hills,  CA  92653
Correspondent Contact JO STEGWELL
Regulation Number878.4200
Classification Product Code
GBZ  
Date Received08/17/1992
Decision Date 02/10/1993
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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