510(k) K903994
- Device
- URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION
- Applicant
- APPLIED UROLOGY, INC.
- 510(k) number
- K903994
- Product code
- FGF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-10-19
- Date received
- 1990-08-29
- Regulation
- 876.5130
- Classification name
- Catheter, Ureteral Disposable (x-ray)
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JO STEGWELL
- Address
- 26051 Merit Cir. Bldg. 104 Launa Hills CA US 92653 92653
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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