The following data is part of a premarket notification filed by Cdb Corp. with the FDA for Reflections.
Device ID | K934881 |
510k Number | K934881 |
Device Name: | REFLECTIONS |
Classification | Bracket, Metal, Orthodontic |
Applicant | CDB CORP. 3625 HIGHWAY 421 NORTH Wilmington, NC 28401 |
Contact | Eric Moschik |
Correspondent | Eric Moschik CDB CORP. 3625 HIGHWAY 421 NORTH Wilmington, NC 28401 |
Product Code | EJF |
CFR Regulation Number | 872.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-12 |
Decision Date | 1994-02-01 |