510(k) K910196
- Device
- BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS
- Applicant
- C.R. BARD, INC.
- 510(k) number
- K910196
- Product code
- FGH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-03-27
- Date received
- 1991-01-16
- Regulation
- 876.5130
- Classification name
- Catheter, Double Lumen Female Urethrographic
- 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
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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