The following data is part of a premarket notification filed by Mediflex Intl. with the FDA for Hemodialysis Transducer Protector.
| Device ID | K900841 |
| 510k Number | K900841 |
| Device Name: | HEMODIALYSIS TRANSDUCER PROTECTOR |
| Classification | Protector, Transducer, Dialysis |
| Applicant | MEDIFLEX INTL. 45 KULICK RD. Fairfield, NJ 07006 |
| Contact | Udine |
| Correspondent | Udine MEDIFLEX INTL. 45 KULICK RD. Fairfield, NJ 07006 |
| Product Code | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-22 |
| Decision Date | 1990-05-15 |