The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Lea Filter (lipid Emulsion Filter) (i.v. Filter).
| Device ID | K954331 |
| 510k Number | K954331 |
| Device Name: | PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) |
| Classification | Filter, Infusion Line |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 2200 NORTHERN BLVD. East Hills, NY 11548 |
| Contact | Robert A Dickstein |
| Correspondent | Robert A Dickstein PALL BIOMEDICAL PRODUCTS CO. 2200 NORTHERN BLVD. East Hills, NY 11548 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-15 |
| Decision Date | 1997-01-09 |