VITREON(R)
Device Facts
| Record ID | P910068 |
|---|---|
| Device Name | VITREON(R) |
| Applicant | Air Products & Chemicals, Inc. |
| Product Code | LWL · Ophthalmic |
| Decision Date | Sep 30, 1997 |
| Decision | APWD |
| Regulation | 21 CFR 886.4275 |
| Device Class | Class 3 |
| Attributes | Expedited Review |
Regulatory Classification
Identification
An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
