FDA 510(k), K132500, CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
FDA 510(k), K132500, CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
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510(K) Number: K132500
Device Name: CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
Manufacturer: CURE MEDICAL LLC.
Device Classification Name: Catheter, Straight
Regulation Number: 876.5130
Classification Product Code: EZD
Date Received: 08/09/2013
Decision Date: 12/23/2013
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
Manufacturer: CURE MEDICAL LLC.
Device Classification Name: Catheter, Straight
Regulation Number: 876.5130
Classification Product Code: EZD
Date Received: 08/09/2013
Decision Date: 12/23/2013
Regulation Medical Specialty: Gastroenterology/Urology
- 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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