The following data is part of a premarket notification filed by Medicia Medical Products with the FDA for Mediziv Infusion Set.
| Device ID | K911128 |
| 510k Number | K911128 |
| Device Name: | MEDIZIV INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDICIA MEDICAL PRODUCTS 88, WEIZMAN ST. Tel-aviv 62264 Israel, IL |
| Contact | Ben-zion Shabtai |
| Correspondent | Ben-zion Shabtai MEDICIA MEDICAL PRODUCTS 88, WEIZMAN ST. Tel-aviv 62264 Israel, IL |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-14 |
| Decision Date | 1991-09-06 |