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 |