The following data is part of a premarket notification filed by Imed Corp. with the FDA for Filterset 0.22, I.v. Pump.
Device ID | K790108 |
510k Number | K790108 |
Device Name: | FILTERSET 0.22, I.V. PUMP |
Classification | Set, Administration, Intravascular |
Applicant | IMED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-16 |
Decision Date | 1979-03-06 |