The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Aef Posidyne I.v. Filter/air Eliminator.
| Device ID | K850825 |
| 510k Number | K850825 |
| Device Name: | AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR |
| Classification | Filter, Infusion Line |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Contact | Sidney Krakauer |
| Correspondent | Sidney Krakauer 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 | 1985-02-28 |
| Decision Date | 1985-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30636207301193 | K850825 | 000 |
| 30636207300936 | K850825 | 000 |
| 30636207300905 | K850825 | 000 |
| 30636207000348 | K850825 | 000 |
| 30636207000331 | K850825 | 000 |
| 30636207000324 | K850825 | 000 |
| 30636207000126 | K850825 | 000 |