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#
- 1834331
- 3042248499
- 3010009693
- 1526534
- 3008264111
- 3017397663
- 3004513872
- 3009760038
- 2084346
- 1043534
- 3018094310
- 9610809
- 3009546990
- 3010536692
- 3012447612
- 3015451162
- 8010379
- 3006846753
- 3005677016
- 1828464
- 3012358417
- 3003120897
- 1722511
- 3006487092
- 2530808
- 1835296
- 3009165919
- 3008650117
- 9611278
- 3003477135
- 3006395932
- 3019455
- 3008544874
- 1835998
- 3003694247
- 3010363503
- 3011577940
- 3004371426
- 3012267976
- 1057425
- 9613350
- 9680059
- 3015877656
- 2249418
- 3038187464
- 8031020
- 1822565
- 3004641308
- 8010935
- 3004153896
- 8043769
- 9681642
- 3021723305
- 3007410669
- 3008110533
- 3006801265
- 9616246
- 3005031160
- 3030989819
- 3015516266
- 3010303097
- 1835251
- 3009590742
- 9614438
- 3007728266
- 3015167917
- 1827096
- 1720747
- 3002834291
- 3012130008
- 3007366790
- 3010646402
- 3016050940
- 1526439
- 3027614879
- 3005641619
- 2249697
- 3009241418
- 3013273457
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 |