The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Irri-cath.
Device ID | K833908 |
510k Number | K833908 |
Device Name: | IRRI-CATH |
Classification | Catheters, Suction, Tracheobronchial |
Applicant | PORTEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-14 |
Decision Date | 1984-02-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() IRRI-CATH 73495054 1336487 Live/Registered |
Portex, Inc. 1984-08-15 |