510(k) K890167
- Device
- HOLDER, NEEDLE
- Applicant
- DHASON BROTHERS, INC.
- 510(k) number
- K890167
- Product code
- HXK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-02-03
- Date received
- 1989-01-09
- Regulation
- 888.4540
- Classification name
- Holder, Needle; Orthopedic
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT DHASON
- Address
- 1705 Merrimak Dr. Hyattsville MD US 20783 20783
FDA Registration Numbers#
- 3010055973
- 2248030
- 9616088
- 1061124
- 3008808049
- 3016825318
- 3015489699
- 1032347
- 9616250
- 1828464
- 3003882387
- 3013358456
- 1818910
- 8010370
- 3038195984
- 3003694247
- 3024988980
- 3043355002
- 3005809810
- 3015167917
- 3010039400
- 3043047788
- 3015451162
- 3033536312
- 3011137372
- 3014201171
- 2936485
- 9611813
- 3004371426
- 3009703496
- 3016443334
- 8043769
- 2031910
- 3004168759
- 3012358417
- 3002675176
- 3004187715
- 3012656745
- 3006524618
- 3016096142
- 8010269
- 3003120897
- 3003687489
- 3003431869
- 3003038445
- 9611112
- 3015259876
- 1825034
- 3002807115
- 3008114965
- 3008338766
- 3002808270
- 4488
- 3014314985
- 1066741
- 3008285983
- 3008902714
- 3031564283
- 3001620590
- 2027754
- 3015895045
- 1055890
- 3010726901
- 3003675041
- 9614062
- 3009513193
- 3035366890
- 8010732
- 3015487912
- 8010422
- 1211566
- 3023657851
- 1220477
- 3003526896
- 3010288346
- 3009499159
- 3003528228
- 8040373
- 3013938829
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HXK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872989 | MICRINS NEEDLE HOLDER | Micrins Surgical, Inc. | 1987-08-21 |
| K860018 | FISCHER WIRE/PIN CLAMP | Buckman Co., Inc. | 1986-02-07 |
| K801594 | ACE FISCHER EXTERNAL FIXATION DEVICE | Ace Orthopedic Manufacturing Co. | 1980-09-09 |
| K772388 | CONVERSE-GILLIES NEEDLE HOLDER | Edward Weck, Inc. | 1978-01-20 |
Legacy Summary#
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FDA Review#
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