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FDA 510(k), K140938, OSTOM-I ALERT
FDA 510(k), K140938, OSTOM-I ALERT
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510(K) Number: K140938
Device Name: OSTOM-I ALERT
Manufacturer: 11 HEALTH AND TECHNOLOGIES LLC
Device Classification Name: collector, ostomy
Regulation Number: 876.5900
Classification Product Code: EXB
Date Received: 04/11/2014
Decision Date: 10/10/2014
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: OSTOM-I ALERT
Manufacturer: 11 HEALTH AND TECHNOLOGIES LLC
Device Classification Name: collector, ostomy
Regulation Number: 876.5900
Classification Product Code: EXB
Date Received: 04/11/2014
Decision Date: 10/10/2014
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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