Baxter Edwards · Class II · Cleared Jul 28, 1995
| K-number | K952638 |
| Device name | 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ |
| Applicant | Baxter Edwards |
| Product code | LYK |
| Device class | Class II |
| Decision date | Jul 28, 1995 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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