510(k) K090078
- Device
- KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
- Applicant
- IOP, INC.
- 510(k) number
- K090078
- Product code
- NXM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-05-08
- Date received
- 2009-01-12
- Regulation
- 886.3130
- Classification name
- Prosthesis, Eyelid Spacer/graft, Biologic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JASON MALECKA
- Address
- 3184-B Airway Ave. Costa Mesa CA US 92626 92626
FDA Registration Numbers#
- 1835959
- 3015177648
- 1000393132
- 2242450
Source Documents#
Other 510(k) Records For Product Code NXM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K053622 | SURGISIS OCULAR GRAFT | Iop, Inc. | 2006-03-15 |
Legacy Summary#
summary
FDA Review#
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