The following data is part of a premarket notification filed by Mediflex Intl. with the FDA for Mediflex Transducer Protector.
| Device ID | K863496 |
| 510k Number | K863496 |
| Device Name: | MEDIFLEX TRANSDUCER PROTECTOR |
| Classification | Protector, Transducer, Dialysis |
| Applicant | MEDIFLEX INTL. 30 CHAPIN RD. BOX 2007 Pine Brook, NJ 07058 |
| Contact | Edgar Udine |
| Correspondent | Edgar Udine MEDIFLEX INTL. 30 CHAPIN RD. BOX 2007 Pine Brook, NJ 07058 |
| Product Code | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-09-23 |