The following data is part of a premarket notification filed by R-group Intl. with the FDA for Acti-flex Arterial Extension Set.
| Device ID | K954035 |
| 510k Number | K954035 |
| Device Name: | ACTI-FLEX ARTERIAL EXTENSION SET |
| Classification | Arterial Blood Sampling Kit |
| 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 | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-28 |
| Decision Date | 1995-09-25 |