The following data is part of a premarket notification filed by Mediziv Medical Products 1987 Ltd. with the FDA for I.v. Filter Set.
Device ID | K933523 |
510k Number | K933523 |
Device Name: | I.V. FILTER SET |
Classification | Filter, Infusion Line |
Applicant | MEDIZIV MEDICAL PRODUCTS 1987 LTD. 88 WEIZMAN ST. Tel Aviv, IL 62264 |
Contact | Muri Sani |
Correspondent | Muri Sani MEDIZIV MEDICAL PRODUCTS 1987 LTD. 88 WEIZMAN ST. Tel Aviv, IL 62264 |
Product Code | FPB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-20 |
Decision Date | 1995-05-19 |