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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 K944790
Device Name FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
Applicant
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Applicant Contact MARY JO STEGWELL
Correspondent
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Correspondent Contact MARY JO STEGWELL
Regulation Number878.4200
Classification Product Code
GBZ  
Date Received09/28/1994
Decision Date 11/29/1994
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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