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#
- 3002949614
- 3005677016
- 9611112
- 3020584246
- 9616671
- 3004215117
- 2249529
- 8044102
- 3027614879
- 3010123206
- 1056350
- 1834379
- 3012120772
- 8040278
- 3009051471
- 3010041511
- 3009381600
- 3035678069
- 3003477135
- 1020279
- 3021723305
- 3009973699
- 9611827
- 2183449
- 9611579
- 3015212339
- 3008338766
- 8010769
- 3006487092
- 3007420745
- 3009888740
- 1833053
- 3005751028
- 2134947
- 3003596442
- 3006846753
- 3005031160
- 3011015572
- 1226544
- 3013011598
- 3014967969
- 3009106092
- 1531174
- 3010055973
- 3004641308
- 3007319107
- 3009971621
- 3010123256
- 1221934
- 3010039400
- 3006809628
- 1000517406
- 3017397663
- 3007993775
- 3005641619
- 1722511
- 1822565
- 3014207283
- 1030489
- 3013273457
- 3010646402
- 3007289093
- 3020155054
- 2031966
- 8031020
- 3005273623
- 3010057495
- 9613910
- 3013194153
- 2249615
- 1836546
- 8043792
- 3013680140
- 1032347
- 3004142400
- 1424434
- 3008773560
- 3034525
- 3012267976
- 3015451162
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 |