The following data is part of a premarket notification filed by Churchill Corp. with the FDA for Churchill Tpn Administration Set.
Device ID | K872123 |
510k Number | K872123 |
Device Name: | CHURCHILL TPN ADMINISTRATION SET |
Classification | Set, Administration, Intravascular |
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 | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-01 |
Decision Date | 1987-10-09 |