The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Autologous Blood Processing System.
| Device ID | K913181 |
| 510k Number | K913181 |
| Device Name: | AUTOLOGOUS BLOOD PROCESSING SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
| Contact | Lucas Gordon |
| Correspondent | Lucas Gordon LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-18 |
| Decision Date | 1992-05-20 |