The following data is part of a premarket notification filed by Life-tech, Inc. with the FDA for Prlong, Models Pl50, Pl100, Pl-40c, Pl-50c, Pl-100c, Pl-150c, Plt-40c, Plt-50c, Plt-100c, Plt-150c.
| Device ID | K082923 |
| 510k Number | K082923 |
| Device Name: | PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C |
| Classification | Apparatus, Autotransfusion |
| Applicant | LIFE-TECH, INC. 4235 GREENBRIAR DR. Stafford, TX 77477 -3995 |
| Contact | Jeff Kasoff |
| Correspondent | Jeff Kasoff LIFE-TECH, INC. 4235 GREENBRIAR DR. Stafford, TX 77477 -3995 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-01 |
| Decision Date | 2008-10-24 |