The following data is part of a premarket notification filed by Stick Tech Ltd. with the FDA for Stick Flow.
Device ID | K031341 |
510k Number | K031341 |
Device Name: | STICK FLOW |
Classification | Material, Tooth Shade, Resin |
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 | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-04-28 |
Decision Date | 2003-10-29 |
Summary: | summary |