The following data is part of a premarket notification filed by Hospital Products Co. with the FDA for Deseret I.v. Filter.
Device ID | K801602 |
510k Number | K801602 |
Device Name: | DESERET I.V. FILTER |
Classification | Filter, Infusion Line |
Applicant | HOSPITAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-07-14 |
Decision Date | 1980-08-27 |