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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Choledochoscope And Accessories, Flexible/Rigid
510(k) Number K951191
Device Name FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
Applicant
PENTAX PRECISION INSTRUMENT CORP.
3117 COMMERCE PKWY.
MIRAMAR,  FL  33025
Applicant Contact PAUL SILVA
Correspondent
PENTAX PRECISION INSTRUMENT CORP.
3117 COMMERCE PKWY.
MIRAMAR,  FL  33025
Correspondent Contact PAUL SILVA
Regulation Number876.1500
Classification Product Code
FBN  
Subsequent Product Code
FGA  
Date Received03/16/1995
Decision Date 05/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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