The following data is part of a premarket notification filed by L.d. Caulk Co. with the FDA for Sealant, New Filled.
Device ID | K760405 |
510k Number | K760405 |
Device Name: | SEALANT, NEW FILLED |
Classification | Sealant, Pit And Fissure, And Conditioner |
Applicant | L.D. CAULK CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBC |
CFR Regulation Number | 872.3765 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-09 |
Decision Date | 1976-08-23 |