The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Stockert Air Purge Control System Model 23-45-05.
| Device ID | K103469 |
| 510k Number | K103469 |
| Device Name: | STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 |
| Classification | Detector, Bubble, 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 | KRL |
| CFR Regulation Number | 870.4205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-24 |
| Decision Date | 2011-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04033817901693 | K103469 | 000 |