The following data is part of a premarket notification filed by B. Braun Medizintechnologie Gmbh with the FDA for Solcart B.
Device ID | K072760 |
510k Number | K072760 |
Device Name: | SOLCART B |
Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
Applicant | B. BRAUN MEDIZINTECHNOLOGIE GMBH 901 MARCON BOULEVARD Allentown, PA 18109 -9341 |
Contact | Tracy Maddock |
Correspondent | Tracy Maddock B. BRAUN MEDIZINTECHNOLOGIE GMBH 901 MARCON BOULEVARD Allentown, PA 18109 -9341 |
Product Code | KPO |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-28 |
Decision Date | 2008-01-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04046963332730 | K072760 | 000 |
04046963332709 | K072760 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SOLCART B 77194577 3713720 Live/Registered |
B.BRAUN AVITUM AG 2007-05-31 |