510(k) K854870
- Device
- Intraocular Electromagnet
- Applicant
- MIRA, INC.
- 510(k) number
- K854870
- Product code
- HPO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-02-19
- Date received
- 1985-12-04
- Regulation
- 886.4440
- Classification name
- Magnet, Ac-Powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK W FURLONG
- Address
- 87 Rumford Ave. Waltham MA US 02453 02453
FDA Registration Numbers#
- 3043709874
Source Documents#
510(k) summary PDF not indicated by FDA