The following data is part of a premarket notification filed by L.d. Caulk Co. with the FDA for Valiant.
Device ID | K801690 |
510k Number | K801690 |
Device Name: | VALIANT |
Classification | Alloy, Amalgam |
Applicant | L.D. CAULK CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJJ |
CFR Regulation Number | 872.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-07-23 |
Decision Date | 1980-08-13 |