The following data is part of a premarket notification filed by Stick Tech Ltd. with the FDA for Stick Net.
Device ID | K003334 |
510k Number | K003334 |
Device Name: | STICK NET |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
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 | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-25 |
Decision Date | 2001-01-08 |