The following data is part of a premarket notification filed by Churchill Corp. with the FDA for Extension Tube Pump Set.
Device ID | K871085 |
510k Number | K871085 |
Device Name: | EXTENSION TUBE PUMP SET |
Classification | Tubing, Fluid Delivery |
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 | FPK |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-18 |
Decision Date | 1987-06-15 |