The following data is part of a premarket notification filed by Carmel Pharma Ab. with the FDA for Phaseal, Closed System Forhandling Of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro.
| Device ID | K980381 |
| 510k Number | K980381 |
| Device Name: | PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | CARMEL PHARMA AB. BOX 5352 Gothenburg, SE 40228 |
| Contact | Britt Noven |
| Correspondent | Britt Noven CARMEL PHARMA AB. BOX 5352 Gothenburg, SE 40228 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-02 |
| Decision Date | 1998-03-03 |
| Summary: | summary |