510(k) K790340
- Device
- Delta-rol
- Applicant
- JOHNSON & JOHNSON PROFESSIONALS, INC.
- 510(k) number
- K790340
- Product code
- GCO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-04-12
- Date received
- 1979-02-21
- Regulation
- 876.1500
- Classification name
- Endoscope, Mirror
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
Source Documents#
510(k) summary PDF not indicated by FDA