The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Dideco Compact-a And Compact-m Autotransfusion Systems.
| Device ID | K963759 |
| 510k Number | K963759 |
| Device Name: | DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS |
| Classification | Apparatus, Autotransfusion |
| Applicant | SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92713 -9503 |
| Contact | Susan J Reimers |
| Correspondent | Susan J Reimers SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92713 -9503 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-18 |
| Decision Date | 1998-02-20 |
| Summary: | summary |