The following data is part of a premarket notification filed by R-group Intl. with the FDA for R-group International Coiled Low Pressure Extension Line.
| Device ID | K940319 |
| 510k Number | K940319 |
| Device Name: | R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE |
| Classification | Set, Administration, Intravascular |
| Applicant | R-GROUP INTL. P.O. BOX 7235 2321 NW 66TH COURT, SUITE W4 Gainesville, FL 32653 |
| Contact | Mark J Kahn |
| Correspondent | Mark J Kahn R-GROUP INTL. P.O. BOX 7235 2321 NW 66TH COURT, SUITE W4 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 | 1994-01-24 |
| Decision Date | 1994-11-10 |