The following data is part of a premarket notification filed by Williams Importing Company, Inc. with the FDA for Oco Preparations.
Device ID | K874396 |
510k Number | K874396 |
Device Name: | OCO PREPARATIONS |
Classification | Bracket, Metal, Orthodontic |
Applicant | WILLIAMS IMPORTING COMPANY, INC. P.O. BOX 1440 Hampton, NH 03842 |
Contact | Peter Hopkin |
Correspondent | Peter Hopkin WILLIAMS IMPORTING COMPANY, INC. P.O. BOX 1440 Hampton, NH 03842 |
Product Code | EJF |
CFR Regulation Number | 872.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-28 |
Decision Date | 1988-05-18 |