The following data is part of a premarket notification filed by Estracorporeal, Inc. with the FDA for Mat Membrane Autotransfusion System.
| Device ID | K915130 |
| 510k Number | K915130 |
| Device Name: | MAT MEMBRANE AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | ESTRACORPOREAL, INC. 4555 PEACH ST. Salt Lake City, UT 84117 |
| Contact | Udipi R.shettigar |
| Correspondent | Udipi R.shettigar ESTRACORPOREAL, INC. 4555 PEACH ST. Salt Lake City, UT 84117 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-13 |
| Decision Date | 1993-02-22 |