KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
FDA 510(k) clearance K090078 · decided 2009-05-08
Clearance details
- K-number
- K090078
- Device name
- KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
- Applicant
- Iop, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-01-12
- Decision date
- 2009-05-08
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- NXM
- Device class
- 2
- Regulation number
- 886.3130
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Costa Mesa, CA, 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 |
|---|---|---|
| SURGISIS OCULAR GRAFT (K053622) | Iop, Inc. | 2006-03-15 |
Recalls involving this device
No recalls on record reference this clearance.