510(k) K843195
- Device
- VISITEC FLIERINGA-LEGRAND FIXATION RING
- Applicant
- VISITEC CO.
- 510(k) number
- K843195
- Product code
- HMH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-10-05
- Date received
- 1984-08-14
- Regulation
- 886.1750
- Classification name
- Rack, Skiascopic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- 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#
- 3009275598
- 3009173773
- 2518410
- 3005785090
- 9613910
- 3011898560
- 3004095901
- 3015972897
- 1418300
- 3003951061
- 2085143
- 1820463
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HMH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K844364 | SKIASCOPIC RACKS | Luneau Laboratories | 1985-01-02 |
Legacy Summary#
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FDA Review#
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