510(k) K931678
- Device
- ORTHOMET LHMC FEMORAL STEM
- Applicant
- ORTHOMET, INC.
- 510(k) number
- K931678
- Product code
- HMC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-10-14
- Date received
- 1993-04-06
- Regulation
- 886.1510
- Classification name
- Monitor, Eye Movement, Diagnostic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID A CANNISTRACI
- Address
- 6301 Cecilia Cir. Minneapolis MN US 55439 55439
Source Documents#
Legacy Summary#
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FDA Review#
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