The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Constavac Blood Conservation System Ii (cbcii).
| Device ID | K952224 |
| 510k Number | K952224 |
| Device Name: | STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) |
| Classification | Apparatus, Autotransfusion |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Tammy Lounds |
| Correspondent | Tammy Lounds STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. 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 | 1995-05-12 |
| Decision Date | 1995-11-17 |