The following data is part of a premarket notification filed by I.z.i. Corp. with the FDA for E.z. Port(tm) Radiation Therapy Skin Markers.
| Device ID | K922287 |
| 510k Number | K922287 |
| Device Name: | E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | I.Z.I. CORP. 10 STREAM CT. Owings Mills, MD 21117 |
| Contact | James Zinreich |
| Correspondent | James Zinreich I.Z.I. CORP. 10 STREAM CT. Owings Mills, MD 21117 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-15 |
| Decision Date | 1992-10-16 |