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#
- 3010097171
- 3003694247
- 3015882686
- 2031966
- 1424263
- 9610809
- 3010314800
- 3015183635
- 3003596442
- 1043534
- 9680411
- 3007420745
- 3012447612
- 1935627
- 3011577940
- 1825034
- 9613910
- 3020584246
- 3042248499
- 8010769
- 9616246
- 3010009693
- 3009971621
- 9616250
- 3014252644
- 3009590742
- 3030989819
- 3005180920
- 3007051929
- 2249418
- 8043769
- 3026311512
- 3013791180
- 3008770707
- 1057425
- 3035708926
- 1722511
- 3006563559
- 3005067367
- 3011137372
- 3012130008
- 9616944
- 3005641619
- 3038187464
- 3038503932
- 2183449
- 2916714
- 1219518
- 3002834291
- 3010370500
- 3012267976
- 3003139373
- 3007319107
- 3021723305
- 2249697
- 1836546
- 3010057495
- 9680304
- 1835296
- 1835998
- 3014662844
- 3005695838
- 3007728266
- 3009760038
- 1649390
- 9611112
- 3013011598
- 9680518
- 3010287737
- 3010041511
- 3009631939
- 1030489
- 3002949614
- 3009513193
- 3020155054
- 3013756169
- 8010665
- 3004641308
- 3000931034
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 |