| K-number | K920539 |
| Device name | ORWO X-RAY FILM |
| Applicant | Burkhart Roentgen Intl., Inc. |
| Product code | IWZ |
| Device class | Class I |
| Decision date | Jun 30, 1992 |
| Decision | Substantially Equivalent |
| Regulation | 892.1840 |
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