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FDA 510(k), K991288, DISTENDER SERIES II BAROSTAT
FDA 510(k), K991288, DISTENDER SERIES II BAROSTAT
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510(K) Number: K991288
Device Name: DISTENDER SERIES II BAROSTAT
Manufacturer: SAM JUNDLER
Device Classification Name: System, Gastrointestinal Motility (Electrical)
Regulation Number: FFX
Classification Product Code: 04/14/1999
Date Received: 06/08/1999
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: DISTENDER SERIES II BAROSTAT
Manufacturer: SAM JUNDLER
Device Classification Name: System, Gastrointestinal Motility (Electrical)
Regulation Number: FFX
Classification Product Code: 04/14/1999
Date Received: 06/08/1999
Decision Date: Substantially Equivalent (SESE)
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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