510(k) K911329
- Device
- Bard(r) Surecatch Pediatric Urine Collect Device
- Applicant
- C.R. BARD, INC.
- 510(k) number
- K911329
- Product code
- FOC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-05-28
- Date received
- 1991-03-26
- Regulation
- 876.5250
- Classification name
- Bag, Urine Collection, Newborn
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONNA J WILSON
- Address
- 8195 Industrial Blvd. Covington GA US 30014 30014
FDA Registration Numbers#
- 3013557562
- 9680340
- 3008850249
- 3018762668
- 3030733800
- 1836161
- 1048735
- 3031981428
- 3030516433
- 3018077422
Source Documents#
510(k) summary PDF not indicated by FDA