The following data is part of a premarket notification filed by Akron Catheter, Inc. with the FDA for Kelly Inflatable T Drain.
Device ID | K823428 |
510k Number | K823428 |
Device Name: | KELLY INFLATABLE T DRAIN |
Classification | Stents, Drains And Dilators For The Biliary Ducts |
Applicant | AKRON CATHETER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FGE |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-16 |
Decision Date | 1983-01-18 |