510(k) K801327
- Device
- The Extractor I Tm
- Applicant
- THE ANSPACH EFFORT, INC.
- 510(k) number
- K801327
- Product code
- HWB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-06-09
- Date received
- 1980-06-03
- Regulation
- 888.4540
- Classification name
- Extractor
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010123206
- 1219518
- 3042508254
- 1835251
- 9616250
- 3003694247
- 3002834291
- 8010916
- 3009380063
- 3012523063
- 8040278
- 1824199
- 1649390
- 3013055499
- 3012131184
- 3010041511
- 3010370500
- 3012447612
- 3008338766
- 3006563559
- 3015876273
- 1720747
- 1450662
- 3015882686
- 3010055973
- 3011600579
- 9610809
- 3008114965
- 3010057495
- 3006801265
- 3003387384
- 9615674
- 3009446038
- 3014967969
- 8030607
- 3026311512
- 1000432246
- 3010646402
- 3013011598
- 1835998
- 3014252644
- 3005031160
- 9681642
- 3015451162
- 3015877656
- 1056350
- 1649379
- 3006179046
- 3010039400
- 3010314800
- 1032347
- 3009631939
- 3005751028
- 9611274
- 3015212339
- 3017565094
- 2249615
- 3008812560
- 3007051929
- 3011015572
- 9614438
- 3009971621
- 3013875765
- 3011137372
- 3009381600
- 3008544874
- 1030489
- 3004641308
- 8010250
- 1526439
- 8010379
- 3004371426
- 1057425
- 3005641619
- 3013564228
- 3010009693
- 3009882675
- 1836357
- 3034525
- 1935627
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HWB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K873710 | MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350 | Arthropedics, Inc. | 1987-11-02 |
| K870844 | SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR | Warsaw Orthopedic, Inc. | 1987-03-13 |
| K870083 | FERRAY EXTRACTOR | Terray Manufacturing, Inc. | 1987-02-26 |
| K780300 | HIP PLATE REMOVAL INSTRUMENT | Richard'S Medical Equip., Inc. | 1978-02-28 |