| K-number | K911349 |
| Device name | E-Z-EM ENTEROCLYSIS CATHETER SET |
| Applicant | E-Z-Em, Inc. |
| Product code | EZK |
| Device class | Class II |
| Decision date | Nov 16, 1992 |
| Decision | Substantially Equivalent |
| Regulation | 876.5980 |
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