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FDA 510(k), K971320, CRE BALLOON DILATATION CATHETER
FDA 510(k), K971320, CRE BALLOON DILATATION CATHETER
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510(K) Number: K971320
Device Name: CRE BALLOON DILATATION CATHETER
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: dilator, esophageal
Regulation Number: 876.5365
Classification Product Code: KNQ
Date Received: 04/10/1997
Decision Date: 10/09/1997
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: CRE BALLOON DILATATION CATHETER
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: dilator, esophageal
Regulation Number: 876.5365
Classification Product Code: KNQ
Date Received: 04/10/1997
Decision Date: 10/09/1997
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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