510(k) K851555
- Device
- OPTHALMIC BAR PRISM
- Applicant
- ROSEBURG SA
- 510(k) number
- K851555
- Product code
- HKW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-23
- Date received
- 1985-04-16
- Regulation
- 886.1650
- Classification name
- Prism, Bar, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHAMBORD
- Address
- 1054 31st St., NW Suite 120 Canal Sq. Washington DC US 20007 20007
FDA Registration Numbers#
- 3009027787
- 3009275598
- 3009518015
- 3009173773
- 3013436538
- 2518410
- 3005785090
- 3006550126
- 3011898560
- 1820463
- 3004095901
- 3007817024
- 3003860739
- 3003951061
- 2085143
- 3014326859
- 3003860763
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HKW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K911374 | PLASTIC OVERLAYS | National Reading Service | 1991-07-26 |
Legacy Summary#
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FDA Review#
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