The following data is part of a premarket notification filed by Pall Corp. with the FDA for Pall Doner Pre-evacuated Post-operative Autologous Blood Reinfusion System.
| Device ID | K022167 |
| 510k Number | K022167 |
| Device Name: | PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | PALL CORP. 2200 NORTHERN BLVD. East Hills, NY 11548 |
| Contact | Leonard S Berman |
| Correspondent | Leonard S Berman PALL CORP. 2200 NORTHERN BLVD. East Hills, NY 11548 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-03 |
| Decision Date | 2003-03-07 |
| Summary: | summary |