The following data is part of a premarket notification filed by The Kendall Company Div. Of Tyco Healthcare Group with the FDA for Connecting Tubing.
Device ID | K831082 |
510k Number | K831082 |
Device Name: | CONNECTING TUBING |
Classification | Tubing, Pressure And Accessories |
Applicant | THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BYX |
CFR Regulation Number | 868.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-04 |
Decision Date | 1983-05-09 |