The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Cbc/constavac Blood Conservation System.
| Device ID | K881350 |
| 510k Number | K881350 |
| Device Name: | CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 |
| Contact | Harmon Woodworth |
| Correspondent | Harmon Woodworth STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-30 |
| Decision Date | 1988-09-30 |