The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Rigid Suction Tips.
Device ID | K822255 |
510k Number | K822255 |
Device Name: | RIGID SUCTION TIPS |
Classification | Tube, Aspirating, Bronchoscope, Rigid |
Applicant | KELLEHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KTR |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-29 |
Decision Date | 1982-08-25 |