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#
- 3004521401
- 3004215117
- 8010099
- 3010041511
- 3011295718
- 1923569
- 3010687973
- 3007841013
- 1020279
- 3009973699
- 3010041430
- 3007420745
- 3015536181
- 1833053
- 3010235355
- 3009959868
- 3003637761
- 3007319107
- 3010220595
- 1530390
- 3007289093
- 3014302784
- 3007887127
- 3015179588
- 3016237080
- 3010045785
- 3015393204
- 3004142400
- 3005587147
- 3013946322
- 1221763
- 8020712
- 1219518
- 3006215390
- 3004788213
- 3009468807
- 2531477
- 3004549189
- 3004153896
- 1526439
- 9615765
- 8010155
- 2529846
- 3026771806
- 2027467
- 8040884
- 3005739886
- 3027305775
- 1644408
- 3008534770
- 3015487912
- 3009158523
- 3004187715
- 3011354099
- 3005874553
- 3037407500
- 1828464
- 1833506
- 3013564228
- 3006946279
- 3004774118
- 3010531060
- 2032830
- 3007125392
- 9617544
- 1818910
- 3009590742
- 3006984710
- 1066741
- 1417592
- 3000327445
- 9611278
- 3014662844
- 3025608439
- 3023265483
- 1000432246
- 3015167917
- 2183570
- 3002498892
Source Documents#
510(k) summary PDF not indicated by FDA