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 |