ORBITAL TISSUE EXPANDER (OTE)
FDA 510(k) clearance K060151 · decided 2006-08-08
Clearance details
- K-number
- K060151
- Device name
- ORBITAL TISSUE EXPANDER (OTE)
- Applicant
- Innovia, LLC
- Decision
- Substantially Equivalent
- Date received
- 2006-01-20
- Decision date
- 2006-08-08
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- NFM
- Device class
- 2
- Regulation number
- 886.3320
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OSMED TISSUE EXPANDER (K010852) | Iop, Inc. | 2001-08-13 |
Recalls involving this device
No recalls on record reference this clearance.