The following data is part of a premarket notification filed by I.z.i. Medical Products Corp. with the FDA for Topographic Imaging Marker.
| Device ID | K962606 |
| 510k Number | K962606 |
| Device Name: | TOPOGRAPHIC IMAGING MARKER |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | I.Z.I. MEDICAL PRODUCTS CORP. 10 STREAM COURT Owings Mills, MD 21117 |
| Contact | S. James Zinreich |
| Correspondent | S. James Zinreich I.Z.I. MEDICAL PRODUCTS CORP. 10 STREAM COURT Owings Mills, MD 21117 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-02 |
| Decision Date | 1996-08-07 |