Issued: 9/2/11
Region: Southeast
Category: Device 483s
Inspection date range: 8/31/11-9/2/11
Pages: 2
Company: Hydrogel Vision Corp.
7575 Commerce Ct.
Sarasota, FL 34243-3218
Inspector(s): Leo J. Lagrotte
Observations: Design plans that describe or reference the design and development activities and define responsibility for implementation have not been established.