The following data is part of a premarket notification filed by Stick Tech Ltd. with the FDA for Everstick Ortho.
Device ID | K021126 |
510k Number | K021126 |
Device Name: | EVERSTICK ORTHO |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | STICK TECH LTD. 80 PARKWAY WEST Mount Vernon, NY 10552 |
Contact | William Troetel |
Correspondent | William Troetel STICK TECH LTD. 80 PARKWAY WEST Mount Vernon, NY 10552 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-08 |
Decision Date | 2002-05-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15400556008680 | K021126 | 000 |