The following data is part of a premarket notification filed by Mediziv Medical Products 1987 Ltd. with the FDA for Huber Needle Sets.
| Device ID | K933898 |
| 510k Number | K933898 |
| Device Name: | HUBER NEEDLE SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDIZIV MEDICAL PRODUCTS 1987 LTD. 88 WEIZMAN ST. Tel Aviv, IL 62264 |
| Contact | Miri Sani |
| Correspondent | Miri Sani MEDIZIV MEDICAL PRODUCTS 1987 LTD. 88 WEIZMAN ST. Tel Aviv, IL 62264 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-10 |
| Decision Date | 1995-09-27 |