The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall 3n1 Filter.
| Device ID | K905794 |
| 510k Number | K905794 |
| Device Name: | PALL 3N1 FILTER |
| Classification | Filter, Infusion Line |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Contact | Edward A Lemmo |
| Correspondent | Edward A Lemmo PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-27 |
| Decision Date | 1991-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30636207000690 | K905794 | 000 |