The following data is part of a premarket notification filed by Implant Technology, Inc. with the FDA for Communi-trach Tube.
Device ID | K841546 |
510k Number | K841546 |
Device Name: | COMMUNI-TRACH TUBE |
Classification | Tube, Tracheostomy (w/wo Connector) |
Applicant | IMPLANT TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTO |
CFR Regulation Number | 868.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-16 |
Decision Date | 1984-04-30 |