The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Ec Plus 3lpm Max. Filter W/sleeve.
| Device ID | K853987 |
| 510k Number | K853987 |
| Device Name: | PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial 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 | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-27 |
| Decision Date | 1985-12-11 |