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#
- 3037407500
- 3027827832
- 3011061242
- 3010041430
- 3006846753
- 1057425
- 8031020
- 3009971621
- 3006946279
- 3012429289
- 1030489
- 3013820441
- 1032347
- 1835251
- 1834331
- 2249418
- 3004638532
- 9615013
- 1043534
- 3005827567
- 8010300
- 3010536692
- 9617297
- 3011530718
- 3009189869
- 3015393204
- 3005706667
- 2132732
- 1000422168
- 1720747
- 3002498892
- 1646747
- 3003249380
- 9610622
- 2031910
- 3019356409
- 3030691054
- 3006179046
- 3010399422
- 1424434
- 3037007952
- 3004641308
- 3002907620
- 3004358587
- 3034676720
- 3003935342
- 3039169546
- 1219655
- 3004976965
- 3013540005
- 3032747418
- 3011600579
- 1833920
- 3005751028
- 9680825
- 3009513193
- 9614093
- 8010298
- 3003435550
- 3033509898
- 3009790163
- 3010045785
- 3013946322
- 3014334038
- 8043862
- 3005067367
- 9611390
- 2531477
- 3025603301
- 3009582259
- 3005273623
- 3008747271
- 3009973699
- 3011623994
- 3009590742
- 3010047402
- 3014314623
- 3007143290
- 3021010222
Source Documents#
510(k) summary PDF not indicated by FDA