The following data is part of a premarket notification filed by Churchill Corp. with the FDA for Churchill 0.22 Micron Liquid Filter Sets.
Device ID | K880025 |
510k Number | K880025 |
Device Name: | CHURCHILL 0.22 MICRON LIQUID FILTER SETS |
Classification | Filter, Infusion Line |
Applicant | CHURCHILL CORP. ONE SUMMIT SQUARE ROUTE 413 & DOUBLEWOODS ROAD Langhorne, PA 19047 |
Contact | David W Evans |
Correspondent | David W Evans CHURCHILL CORP. ONE SUMMIT SQUARE ROUTE 413 & DOUBLEWOODS ROAD Langhorne, PA 19047 |
Product Code | FPB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-05 |
Decision Date | 1988-04-14 |