510(k) K862689
- Device
- 2.5mm Hex Driver/curve Passer/bone Punch/rasp
- Applicant
- W.L. GORE & ASSOCIATES,INC
- 510(k) number
- K862689
- Product code
- HXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-02
- Date received
- 1986-07-15
- Regulation
- 888.4540
- Classification name
- Screwdriver
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- FREDERICK W DAWSON
- Address
- 3450 W. Kiltie Ln. P.O. Box 500 Flagstaff AZ US 86002 86002
FDA Registration Numbers#
- 3010237768
- 3026576110
- 3004638600
- 3008534770
- 3009546990
- 3006846753
- 3015991317
- 3013820441
- 3003935342
- 3014615697
- 3004176895
- 8010099
- 3014257776
- 3030966822
- 8031020
- 3009189869
- 3012234585
- 3004641308
- 3007410669
- 9615005
- 1833920
- 3014976005
- 3010303097
- 3031261833
- 3007366790
- 9617297
- 3010646402
- 3005641619
- 1017294
- 3011600579
- 1649518
- 3009051471
- 3017075357
- 3013156185
- 3004635447
- 8043971
- 9610612
- 8043933
- 2134947
- 3008583793
- 8010769
- 3016237080
- 8010300
- 8040278
- 3008747271
- 3013546462
- 2132732
- 3010287737
- 2431166
- 3004504812
- 3016443334
- 3003637761
- 3010502940
- 3010097171
- 3010370500
- 3009158523
- 3015876273
- 3010667733
- 3004549189
- 3009882675
- 1226544
- 3007887127
- 3002719998
- 1000517406
- 3002808270
- 3036795921
- 3009973336
- 9613910
- 3009110133
- 1836161
- 3004638532
- 3013846070
- 3010314800
- 3009973505
- 9617544
- 3005809810
- 9611283
- 3010047402
- 3011137372
Source Documents#
510(k) summary PDF not indicated by FDA