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
- 3010055973
- 1221934
- 3009051471
- 3030989819
- 3010314800
- 9611579
- 1649379
- 1032347
- 9616250
- 9614438
- 1836357
- 1828464
- 1526534
- 1818910
- 1000517406
- 3014314623
- 3003694247
- 3015399803
- 3021723305
- 3015167917
- 1424263
- 3011015572
- 8010769
- 3010039400
- 3006128100
- 3005031160
- 3003477135
- 3005641619
- 3007311878
- 2183449
- 3015451162
- 3011137372
- 3033536312
- 3004371426
- 9616671
- 1833986
- 2249615
- 8043769
- 3012358417
- 3033509898
- 1822565
- 3003120897
- 9610809
- 3015877656
- 3011534620
- 3015259876
- 9611112
- 1825034
- 3020155054
- 3008264111
- 3008114965
- 3008338766
- 3010370500
- 3010388970
- 3027614879
- 2249418
- 1834379
- 3007420745
- 8010935
- 3004513872
- 3005751028
- 1038671
- 3009513193
- 3008544874
- 3012447612
- 1057425
- 3015516266
- 3000931034
- 3013043133
- 3035678069
- 3012120772
- 2530808
- 1720747
- 3013194153
- 3000327445
- 1824199
- 3006460162
- 3002498892
- 3013946322
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 |