The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Ec Plus Filter W/filter Sleeve.
| Device ID | K834382 |
| 510k Number | K834382 |
| Device Name: | PALL EC PLUS FILTER W/FILTER SLEEVE |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-14 |
| Decision Date | 1984-08-03 |