510(k) K810503
- Device
- Flexible Choledochoscope/nephroscope
- Applicant
- OLYMPUS CORP.
- 510(k) number
- K810503
- Product code
- NWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-04-03
- Date received
- 1981-02-24
- Regulation
- 876.1500
- Classification name
- Kit, Choledochoscope, Flexible And Rigid
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA