510(k) K890165
- Device
- FORCEPS-ORTHOPEDIC
- Applicant
- DHASON BROTHERS, INC.
- 510(k) number
- K890165
- Product code
- LXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-02-13
- Date received
- 1989-01-09
- Regulation
- 870.4500
- Classification name
- Probe, Test, Heart-valve
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- 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#
- 8044098
- 3012185136
- 1063481
- 3004478276
- 3003477135
- 3031231776
- 2029275
- 1058726
- 1649833
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LXN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881449 | EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 | Baxter Healthcare Corp | 1988-06-15 |
Legacy Summary#
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FDA Review#
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