510(k) K901257
- Device
- Wirontom Clasp Wire
- Applicant
- IVOCLAR NORTH AMERICA, INC.
- 510(k) number
- K901257
- Product code
- EJW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-04-25
- Date received
- 1990-03-15
- Regulation
- 872.3285
- Classification name
- Clasp, Wire
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- L SEVERANCE,DDS
- Address
- 175 Pineview Dr. Amherst NY US 14228 14228
FDA Registration Numbers#
- 3009171220
- 3017903664
- 3012421607
- 1836161
- 3035335007
- 3009711592
- 3008317118
- 2523320
- 9611458
- 8040278
Source Documents#
510(k) summary PDF not indicated by FDA