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FDA 510(k), K941488, DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER
FDA 510(k), K941488, DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER
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510(K) Number: K941488
Device Name: DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER
Manufacturer: MEDICAL TECHNOLOGY DEVELOPMENT CORP.
Device Classification Name: catheter, retention type, balloon
Regulation Number: 876.5130
Classification Product Code: EZL
Date Received: 03/28/1994
Decision Date: 11/30/1994
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER
Manufacturer: MEDICAL TECHNOLOGY DEVELOPMENT CORP.
Device Classification Name: catheter, retention type, balloon
Regulation Number: 876.5130
Classification Product Code: EZL
Date Received: 03/28/1994
Decision Date: 11/30/1994
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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