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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name duodenoscope and accessories, flexible/rigid
510(k) Number K963056
Device Name ED-3410, VIDEO DUODENOSCOPE
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
FDT  
Date Received08/06/1996
Decision Date 10/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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