The following data is part of a premarket notification filed by Carmel Pharma Ab. with the FDA for Infusion Adapter C100.
| Device ID | K110023 |
| 510k Number | K110023 |
| Device Name: | INFUSION ADAPTER C100 |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | CARMEL PHARMA AB. AMINOGATAN 30 Molndal, SE S431 53 |
| Contact | Kjell Andreasson |
| Correspondent | Kjell Andreasson CARMEL PHARMA AB. AMINOGATAN 30 Molndal, SE S431 53 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-03 |
| Decision Date | 2011-04-12 |
| Summary: | summary |