510(k) K934468
- Device
- Slip-on Fixation Splint (sfs)
- Applicant
- GATEWOOD SPLINTS
- 510(k) number
- K934468
- Product code
- EHO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-08-05
- Date received
- 1993-09-10
- Regulation
- 872.3165
- Classification name
- Bar, Preformed
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN B GATEWOOD
- Address
- 5200 Meadowcreek Dr., #1118 Dallas TX US 75248 75248
FDA Registration Numbers#
- 9611112
- 8010372
- 2918719
- 3013156109
- 3007160937
- 3022296393
- 9614404
- 3009968482
- 1836161
- 1923569
- 3042849555
- 3036471634
- 3004193466
- 3026401444
- 3012821743
- 3025583883
- 3009171220
- 1421101
- 3004149679
- 3009711592
- 9613348
- 9681207
- 8010177
- 3009779268
- 9611367
- 9611458
Source Documents#
510(k) summary PDF not indicated by FDA