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#

Source Documents#

510(k) summary PDF not indicated by FDA