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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Panendoscope (Gastroduodenoscope)
510(k) Number K812810
Device Name PENTAX FLEXIBLE DRIODENOFIBERSCOPE
Applicant
PENTAX PRECISION INSTRUMENT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PENTAX PRECISION INSTRUMENT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1500
Classification Product Code
FAK  
Date Received10/06/1981
Decision Date 11/17/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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