The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Braun Manifold.
| Device ID | K942391 |
| 510k Number | K942391 |
| Device Name: | BRAUN MANIFOLD |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. P.O. BOX 4027 Bethlehem, PA 18018 -0027 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. P.O. BOX 4027 Bethlehem, PA 18018 -0027 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-19 |
| Decision Date | 1995-06-21 |