The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace Radiolucent.
| Device ID | K961395 |
| 510k Number | K961395 |
| Device Name: | MEDI-TRACE RADIOLUCENT |
| Classification | Electrode, Electrocardiograph |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo, NY 14240 -1271 |
| Contact | Kathleen Selover |
| Correspondent | Kathleen Selover GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo, NY 14240 -1271 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-11 |
| Decision Date | 1996-06-07 |