The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Stockert S5 System And Gas Blender And Sorin C5 System.
| Device ID | K101046 |
| 510k Number | K101046 |
| Device Name: | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM |
| Classification | Gas Control Unit, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | DTX |
| CFR Regulation Number | 870.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-14 |
| Decision Date | 2010-12-09 |
| Summary: | summary |