510(k) K060151
- Device
- ORBITAL TISSUE EXPANDER (OTE)
- Applicant
- Innovia, LLC
- 510(k) number
- K060151
- Product code
- NFM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-08-08
- Date received
- 2006-01-20
- Regulation
- 886.3320
- Classification name
- Expander, Tissue, Orbital
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- STEWART B DAVIS
- Address
- 12415 SW 136 Ave. Unit 3 Miami FL US 33186 33186
FDA Registration Numbers#
- 3004467263
- 3002991496
- 9615745
- 1018470
Source Documents#
Other 510(k) Records For Product Code NFM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K010852 | OSMED TISSUE EXPANDER | Iop, Inc. | 2001-08-13 |