The following data is part of a premarket notification filed by Stick Tech Ltd. with the FDA for Everstick A&o.
Device ID | K051953 |
510k Number | K051953 |
Device Name: | EVERSTICK A&O |
Classification | Bracket, Plastic, Orthodontic |
Applicant | STICK TECH LTD. 80 PARKWAY WEST Mount Vernon, NY 10552 |
Contact | William M Troetel |
Correspondent | William M Troetel STICK TECH LTD. 80 PARKWAY WEST Mount Vernon, NY 10552 |
Product Code | DYW |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-18 |
Decision Date | 2006-03-21 |
Summary: | summary |