The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Modification To Stockert S5 System.
| Device ID | K062396 |
| 510k Number | K062396 |
| Device Name: | MODIFICATION TO STOCKERT S5 SYSTEM |
| Classification | Console, Heart-lung Machine, 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 | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-16 |
| Decision Date | 2006-09-28 |
| Summary: | summary |