The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Combiprot Emergency Enfusion Device.
| Device ID | K970359 |
| 510k Number | K970359 |
| Device Name: | COMBIPROT EMERGENCY ENFUSION DEVICE |
| Classification | Set, I.v. Fluid Transfer |
| 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 | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-31 |
| Decision Date | 1997-03-18 |
| Summary: | summary |