510(k) K911374
- Device
- PLASTIC OVERLAYS
- Applicant
- NATIONAL READING SERVICE
- 510(k) number
- K911374
- Product code
- HKW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-07-26
- Date received
- 1991-03-28
- 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
- SUMNER BORIN
- Address
- 2104 SW Adams St. Peoria IL US 61602 61602
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 |
|---|---|---|---|
| K851555 | OPTHALMIC BAR PRISM | Roseburg SA | 1985-05-23 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases