The following data is part of a premarket notification filed by B. Braun Of America, Inc. with the FDA for B. Braun Iv Start Kits.
| Device ID | K950184 |
| 510k Number | K950184 |
| Device Name: | B. BRAUN IV START KITS |
| Classification | I.v. Start Kit |
| Applicant | B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem, PA 18018 -0027 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem, PA 18018 -0027 |
| Product Code | LRS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-17 |
| Decision Date | 1995-03-15 |