The following data is part of a premarket notification filed by Intl. Medical, Inc. with the FDA for Durham; Luer Lock Extension Set.
| Device ID | K930410 |
| 510k Number | K930410 |
| Device Name: | DURHAM; LUER LOCK EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | INTL. MEDICAL, INC. 6 DURHAM BOAT DR. Washington Crossing, PA 18977 |
| Contact | John Romano |
| Correspondent | John Romano INTL. MEDICAL, INC. 6 DURHAM BOAT DR. Washington Crossing, PA 18977 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-26 |
| Decision Date | 1993-09-03 |