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FDA 510(k), K972964, ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
FDA 510(k), K972964, ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
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510(K) Number: K972964
Device Name: ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
Manufacturer: ATRION MEDICAL PRODUCTS, INC.
Device Classification Name: dilator, urethral
Regulation Number: 876.5520
Classification Product Code: KOE
Date Received: 08/11/1997
Decision Date: 10/10/1997
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
Manufacturer: ATRION MEDICAL PRODUCTS, INC.
Device Classification Name: dilator, urethral
Regulation Number: 876.5520
Classification Product Code: KOE
Date Received: 08/11/1997
Decision Date: 10/10/1997
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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