The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Shiley Therapeutic Autotransfusion System (remote).
| Device ID | K872814 |
| 510k Number | K872814 |
| Device Name: | SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (REMOTE) |
| Classification | Apparatus, Autotransfusion |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Ganz Pobuda |
| Correspondent | Ganz Pobuda SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-16 |
| Decision Date | 1987-08-05 |