The following data is part of a premarket notification filed by B. Braun Of America, Inc. with the FDA for Chemo Mini Spike Plus.
| Device ID | K983794 |
| 510k Number | K983794 |
| Device Name: | CHEMO MINI SPIKE PLUS |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | B. BRAUN OF AMERICA, INC. 901 MARCON BLVD. Allentown, PA 18103 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge B. BRAUN OF AMERICA, INC. 901 MARCON BLVD. Allentown, PA 18103 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-27 |
| Decision Date | 1999-03-23 |
| Summary: | summary |