The following data is part of a premarket notification filed by Unomedical A/s with the FDA for Comfort And Inset Subcutaneous Infusion Sets For Use With Abbott Infusion Pumps.
Device ID | K051264 |
510k Number | K051264 |
Device Name: | COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS |
Classification | Set, Administration, Intravascular |
Applicant | UNOMEDICAL A/S AAHOLMVEJ 2, OSTED Roskilde, DK 4000 |
Contact | John Lindskog |
Correspondent | John Lindskog UNOMEDICAL A/S AAHOLMVEJ 2, OSTED Roskilde, DK 4000 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-16 |
Decision Date | 2005-09-01 |
Summary: | summary |