510(k) K070915
- Device
- SAPIMED DISPOSABLE SIGMOIDOSCOPE
- Applicant
- SAPIMED S.P.A.
- 510(k) number
- K070915
- Product code
- KDM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-07-06
- Date received
- 2007-04-02
- Regulation
- 876.1500
- Classification name
- Sigmoidoscope, Rigid, Non-electrical
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- E J SMITH
- Address
- 1676 Village Green Suite A Crofton MD US 21114 21114
FDA Registration Numbers#
- 3004443374
- 3011412640
Source Documents#
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases