The following data is part of a premarket notification filed by Vitalcare Group, Inc. with the FDA for Vitalcare I.v. Administration Set.
| Device ID | K050906 |
| 510k Number | K050906 |
| Device Name: | VITALCARE I.V. ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | VITALCARE GROUP, INC. 8935 NW 27TH STREET Miami, FL 33172 |
| Contact | Michael Mcavenia |
| Correspondent | Michael Mcavenia VITALCARE GROUP, INC. 8935 NW 27TH STREET Miami, FL 33172 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-11 |
| Decision Date | 2005-08-23 |
| Summary: | summary |