The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Air Purge Control System For S5 System Model 23-45-05.
Device ID | K091007 |
510k Number | K091007 |
Device Name: | AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 |
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 | 2009-04-09 |
Decision Date | 2009-07-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04033817902638 | K091007 | 000 |