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FDA 510(k), K812810, PENTAX FLEXIBLE DRIODENOFIBERSCOPE
FDA 510(k), K812810, PENTAX FLEXIBLE DRIODENOFIBERSCOPE
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510(K) Number: K812810
Device Name: PENTAX FLEXIBLE DRIODENOFIBERSCOPE
Manufacturer: PENTAX PRECISION INSTRUMENT CORP.
Device Classification Name: panendoscope (gastroduodenoscope)
Regulation Number: 876.1500
Classification Product Code: FAK
Date Received: 10/06/1981
Decision Date: 11/17/1981
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PENTAX FLEXIBLE DRIODENOFIBERSCOPE
Manufacturer: PENTAX PRECISION INSTRUMENT CORP.
Device Classification Name: panendoscope (gastroduodenoscope)
Regulation Number: 876.1500
Classification Product Code: FAK
Date Received: 10/06/1981
Decision Date: 11/17/1981
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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