The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Diapact Crrt.
| Device ID | K973322 |
| 510k Number | K973322 |
| Device Name: | DIAPACT CRRT |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-04 |
| Decision Date | 1998-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04039239041252 | K973322 | 000 |