The following data is part of a premarket notification filed by R-group Intl. with the FDA for Acti-flex Iv Administration Set.
| Device ID | K001599 |
| 510k Number | K001599 |
| Device Name: | ACTI-FLEX IV ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | R-GROUP INTL. 2321 N.W. 66TH CT., SUITE W-4 Gainesville, FL 32653 |
| Contact | Kerry Anne Kahn |
| Correspondent | Kerry Anne Kahn R-GROUP INTL. 2321 N.W. 66TH CT., SUITE W-4 Gainesville, FL 32653 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-24 |
| Decision Date | 2000-09-18 |