The following data is part of a premarket notification filed by Pall Corp. with the FDA for Pall Stat-prime D Blood Filter For Extracorporeal Service.
| Device ID | K980762 |
| 510k Number | K980762 |
| Device Name: | PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | PALL CORP. 2200 NORTHERN BLVD. East Hills, NY 11548 |
| Contact | Robert A Dickstein, Ph.d. |
| Correspondent | Robert A Dickstein, Ph.d. PALL CORP. 2200 NORTHERN BLVD. East Hills, NY 11548 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-27 |
| Decision Date | 1998-09-01 |