510(k) K844895
- Device
- OMS SILICONE OIL INJECTOR
- Applicant
- OPTICAL MICRO SYSTEMS, INC.
- 510(k) number
- K844895
- Product code
- LWL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-06-24
- Date received
- 1984-12-17
- Regulation
- 886.4275
- Classification name
- Fluid, Intraocular
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GERALD A CLAY
- Address
- 8 Electronics Ave. Danvers MA US 01923 01923
FDA Registration Numbers#
- 9710098
- 1313525
- 1064514
- 3003365815
- 3005689226
- 1610287
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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