The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Ultipor Solution Container Filter.
Device ID | K790879 |
510k Number | K790879 |
Device Name: | ULTIPOR SOLUTION CONTAINER FILTER |
Classification | Filter, Infusion Line |
Applicant | PALL BIOMEDICAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FPB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-07 |
Decision Date | 1979-06-01 |