The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Posidyne I.v. Filter/air Eliminator.
| Device ID | K834381 |
| 510k Number | K834381 |
| Device Name: | POSIDYNE I.V. FILTER/AIR ELIMINATOR |
| Classification | Filter, Infusion Line |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-13 |
| Decision Date | 1984-04-24 |