The following data is part of a premarket notification filed by Carmel Pharma Ab. with the FDA for Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter.
| Device ID | K001368 |
| 510k Number | K001368 |
| Device Name: | PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | CARMEL PHARMA AB. BOX 5352 Gothenburg, SE 40228 |
| Contact | Kjell Andreasson |
| Correspondent | Kjell Andreasson CARMEL PHARMA AB. BOX 5352 Gothenburg, SE 40228 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-01 |
| Decision Date | 2000-05-12 |