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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 K924480
Device Name CHOLANGIOGRAPHY CLAMP
Applicant
Applied Medical Resources
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Applicant Contact HO STEGWELL
Correspondent
Applied Medical Resources
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Correspondent Contact HO STEGWELL
Regulation Number878.4200
Classification Product Code
GBZ  
Date Received09/03/1992
Decision Date 03/03/1993
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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