The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac Ii Autotransfusion System.
| Device ID | K854301 |
| 510k Number | K854301 |
| Device Name: | PLEUR-EVAC II AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
| Contact | Richard J Larkin |
| Correspondent | Richard J Larkin DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-25 |
| Decision Date | 1985-11-19 |