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 | K990242 |
| 510k Number | K990242 |
| Device Name: | TOPOGRAPHIC IMAGING MARKER |
| Classification | System, X-ray, Stationary |
| Applicant | I.Z.I. MEDICAL PRODUCTS CORP. P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E J Smith |
| Correspondent | E J Smith I.Z.I. MEDICAL PRODUCTS CORP. P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-25 |
| Decision Date | 1999-03-03 |