The following data is part of a premarket notification filed by Williams Gold Refining Co., Inc. with the FDA for Dw217 #18 Crown/bridge & Dw218 #24 Ceramic Alloys.
Device ID | K860439 |
510k Number | K860439 |
Device Name: | DW217 #18 CROWN/BRIDGE & DW218 #24 CERAMIC ALLOYS |
Classification | Alloy, Other Noble Metal |
Applicant | WILLIAMS GOLD REFINING CO., INC. 2978 MAIN ST. Buffalo, NY 14214 |
Contact | Lawrence A Williams |
Correspondent | Lawrence A Williams WILLIAMS GOLD REFINING CO., INC. 2978 MAIN ST. Buffalo, NY 14214 |
Product Code | EJS |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-04 |
Decision Date | 1986-03-20 |