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FDA 510(k), K984358, OLYMPUS DISTAL ATTACHMENT
FDA 510(k), K984358, OLYMPUS DISTAL ATTACHMENT
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510(K) Number: K984358
Device Name: OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
Manufacturer: OLYMPUS AMERICA, INC.
Device Classification Name: gastroscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDS
Date Received: 12/07/1998
Decision Date: 09/17/1999
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
Manufacturer: OLYMPUS AMERICA, INC.
Device Classification Name: gastroscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDS
Date Received: 12/07/1998
Decision Date: 09/17/1999
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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