The following data is part of a premarket notification filed by Medelec Intl. Corp. with the FDA for Connector, Blood Tubing, Infusion T. Intravenous I.
| Device ID | K854562 |
| 510k Number | K854562 |
| Device Name: | CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I |
| Classification | Set, Blood Transfusion |
| Applicant | MEDELEC INTL. CORP. ONE LINCOLN ROAD, SUITE 304 Miami Beach, FL 33139 |
| Contact | Oscar D Docal |
| Correspondent | Oscar D Docal MEDELEC INTL. CORP. ONE LINCOLN ROAD, SUITE 304 Miami Beach, FL 33139 |
| Product Code | BRZ |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-14 |
| Decision Date | 1986-01-09 |