The following data is part of a premarket notification filed by Mercury Enterprises, Inc. with the FDA for Tubing Connector #10-810-60 100/pkg Non-sterile.
Device ID | K862722 |
510k Number | K862722 |
Device Name: | TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE |
Classification | Connector, Tubing, Dialysate |
Applicant | MERCURY ENTERPRISES, INC. 4645 - 145TH AVENUE NORTH Clearwater, FL 33520 |
Contact | George Howe |
Correspondent | George Howe MERCURY ENTERPRISES, INC. 4645 - 145TH AVENUE NORTH Clearwater, FL 33520 |
Product Code | FKY |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-17 |
Decision Date | 1986-08-11 |