The following data is part of a premarket notification filed by Teledyne, Inc. with the FDA for Fluor-etch Gel Etchant.
Device ID | K862695 |
510k Number | K862695 |
Device Name: | FLUOR-ETCH GEL ETCHANT |
Classification | Sealant, Pit And Fissure, And Conditioner |
Applicant | TELEDYNE, INC. 1550 GREENLEAF AVE. Elk Grove Village, IL 60007 |
Contact | John Washburn |
Correspondent | John Washburn TELEDYNE, INC. 1550 GREENLEAF AVE. Elk Grove Village, IL 60007 |
Product Code | EBC |
CFR Regulation Number | 872.3765 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-15 |
Decision Date | 1986-07-31 |