The following data is part of a premarket notification filed by Burkhart Roentgen Intl., Inc. with the FDA for Orwo X-ray Film.
| Device ID | K920539 |
| 510k Number | K920539 |
| Device Name: | ORWO X-RAY FILM |
| Classification | Film, Radiographic |
| Applicant | BURKHART ROENTGEN INTL., INC. 6571 43RD ST., NORTH UNIT 1704-1706 Pinellas Park, FL 34665 |
| Contact | Norman Jackvony |
| Correspondent | Norman Jackvony BURKHART ROENTGEN INTL., INC. 6571 43RD ST., NORTH UNIT 1704-1706 Pinellas Park, FL 34665 |
| Product Code | IWZ |
| CFR Regulation Number | 892.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-05 |
| Decision Date | 1992-06-30 |