The following data is part of a premarket notification filed by Williams Gold Refining Co., Inc. with the FDA for Disposable Articulator.
Device ID | K801342 |
510k Number | K801342 |
Device Name: | DISPOSABLE ARTICULATOR |
Classification | Articulators |
Applicant | WILLIAMS GOLD REFINING CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJP |
CFR Regulation Number | 872.3150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-06-05 |
Decision Date | 1980-07-08 |