The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Alastik.
Device ID | K933501 |
510k Number | K933501 |
Device Name: | ALASTIK |
Classification | Bracket, Metal, Orthodontic |
Applicant | UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
Contact | Marlyn Scheff |
Correspondent | Marlyn Scheff UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
Product Code | EJF |
CFR Regulation Number | 872.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-19 |
Decision Date | 1994-04-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ALASTIK 73542299 1439061 Live/Registered |
UNITEK CORPORATION 1985-06-10 |
ALASTIK 72272875 0890975 Dead/Cancelled |
UNITEK CORPORATION 1967-06-01 |