The following data is part of a premarket notification filed by Posey Co. with the FDA for Quicktrach.
Device ID | K874742 |
510k Number | K874742 |
Device Name: | QUICKTRACH |
Classification | Tube, Tracheostomy (w/wo Connector) |
Applicant | POSEY CO. 2443 DELTA LN. Elk Grove Village, IL 60007 |
Contact | Ernest M Posey |
Correspondent | Ernest M Posey POSEY CO. 2443 DELTA LN. Elk Grove Village, IL 60007 |
Product Code | BTO |
CFR Regulation Number | 868.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-18 |
Decision Date | 1987-12-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04250105621709 | K874742 | 000 |
04250105621693 | K874742 | 000 |
04250105612455 | K874742 | 000 |
04250105604993 | K874742 | 000 |
24026704646702 | K874742 | 000 |
24026704646696 | K874742 | 000 |
24250105629983 | K874742 | 000 |
14250105629979 | K874742 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUICKTRACH 76164703 2907480 Live/Registered |
VBM Medizintechnik GmbH 2000-11-14 |