The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace Defib Pads.
| Device ID | K955597 |
| 510k Number | K955597 |
| Device Name: | MEDI-TRACE DEFIB PADS |
| Classification | Media, Electroconductive |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo, NY 14240 -1271 |
| Contact | Susan Krasny |
| Correspondent | Susan Krasny GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo, NY 14240 -1271 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-08 |
| Decision Date | 1996-07-09 |