510(k) K854467
- Device
- S.t.p.b Soft Tissues Protectives Blades
- Applicant
- NORTEX USA, INC.
- 510(k) number
- K854467
- Product code
- EEJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-03-12
- Date received
- 1985-11-06
- Regulation
- 872.6010
- Classification name
- Guard, Disk
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANTOINE CHAMBORD
- Address
- 1032 31st. St. NW Washington DC US 20007 20007
FDA Registration Numbers#
- 9613926
- 3001146947
- 8040278
- 3013552516
- 3012590871
- 3017413151
- 2024980
- 3013946322
- 1937100
- 1526352
- 9611458
- 3006400536
- 8030938
Source Documents#
510(k) summary PDF not indicated by FDA