The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Sorin C5 System Model 58-00-00.
Device ID | K093882 |
510k Number | K093882 |
Device Name: | SORIN C5 SYSTEM MODEL 58-00-00 |
Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
Applicant | SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
Contact | Rosina Robinson, Rn, Med, Rac |
Correspondent | Rosina Robinson, Rn, Med, Rac 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 | 2009-12-18 |
Decision Date | 2010-01-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04033817901440 | K093882 | 000 |
04033817901433 | K093882 | 000 |
04033817901426 | K093882 | 000 |
04033817900924 | K093882 | 000 |