The following data is part of a premarket notification filed by R-group Intl. with the FDA for Acti-flex Low, Medium, Rescare I, Rescare Ii..
| Device ID | K952470 |
| 510k Number | K952470 |
| Device Name: | ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. |
| Classification | Connector, Catheter |
| Applicant | R-GROUP INTL. P.O. BOX 7235 2321 NW 66TH COURT, SUITE W4 Gainesville, FL 32653 |
| Contact | Kerry Anne Kahn |
| Correspondent | Kerry Anne Kahn R-GROUP INTL. P.O. BOX 7235 2321 NW 66TH COURT, SUITE W4 Gainesville, FL 32653 |
| Product Code | GCD |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-26 |
| Decision Date | 1995-11-28 |