The following data is part of a premarket notification filed by Carmel Pharma Ab. with the FDA for Phaseal Protector P14, P21, P28 And P50.
| Device ID | K090634 |
| 510k Number | K090634 |
| Device Name: | PHASEAL PROTECTOR P14, P21, P28 AND P50 |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | CARMEL PHARMA AB. AMINOGATAN 30, MOLNDAL BOX 5352 Gothenburg, SE Se 402 28 |
| Contact | Kjell Andreasson |
| Correspondent | Kjell Andreasson CARMEL PHARMA AB. AMINOGATAN 30, MOLNDAL BOX 5352 Gothenburg, SE Se 402 28 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-09 |
| Decision Date | 2009-03-23 |
| Summary: | summary |