510(k) K000544
- Device
- BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
- Applicant
- LABTICIAN OPHTHALMICS, INC.
- 510(k) number
- K000544
- Product code
- HJX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-03-09
- Date received
- 2000-02-18
- Regulation
- 886.5810
- Classification name
- Reader, Prism, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- R. DAVID SCULATI
- Address
- 2140 Winston Park Dr., Unit 6 Oakville, Ontario CA L6H 5V5 L6H 5V5
FDA Registration Numbers#
- 3010526253
- 3009279940
- 2087075
- 3009858811
- 3004950803
- 3010613909
- 3003951061
- 1418300
- 3030180988
Source Documents#
510(k) summary PDF not indicated by FDA
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