The following data is part of a premarket notification filed by Unomedical A/s Infusion Devices with the FDA for Asante Conset And Asante Comfort Subcutaneous Infusion Sets For Use With Asante Pearl Infusion Pumps.
Device ID | K120872 |
510k Number | K120872 |
Device Name: | ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS |
Classification | Set, Administration, Intravascular |
Applicant | UNOMEDICAL A/S INFUSION DEVICES AAHOLMVEJ 1-3, OSTED Lejre, DK Dk-4320 |
Contact | John M Lindskog |
Correspondent | John M Lindskog UNOMEDICAL A/S INFUSION DEVICES AAHOLMVEJ 1-3, OSTED Lejre, DK Dk-4320 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-03-22 |
Decision Date | 2012-04-20 |
Summary: | summary |