The following data is part of a premarket notification filed by Maersk Medical A/s with the FDA for Maersk Medical Contour Infusion Set.
| Device ID | K991759 |
| 510k Number | K991759 |
| Device Name: | MAERSK MEDICAL CONTOUR INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MAERSK MEDICAL A/S 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Don Selvey |
| Correspondent | Don Selvey MAERSK MEDICAL A/S 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-24 |
| Decision Date | 1999-06-25 |
| Summary: | summary |