The following data is part of a premarket notification filed by Para Scientific Co. with the FDA for Fluortran - C(tm).
| Device ID | K872751 |
| 510k Number | K872751 |
| Device Name: | FLUORTRAN - C(TM) |
| Classification | Device, Specimen Collection |
| Applicant | PARA SCIENTIFIC CO. 4155 MELISSA DR. Lake Oswego, OR 97034 |
| Contact | Eric V Carlson |
| Correspondent | Eric V Carlson PARA SCIENTIFIC CO. 4155 MELISSA DR. Lake Oswego, OR 97034 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-13 |
| Decision Date | 1987-07-23 |