The following data is part of a premarket notification filed by Exco, Inc. with the FDA for Suction Tubes.
Device ID | K822724 |
510k Number | K822724 |
Device Name: | SUCTION TUBES |
Classification | Catheters, Suction, Tracheobronchial |
Applicant | EXCO, 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 | 1982-09-07 |
Decision Date | 1982-10-13 |