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 |