The following data is part of a premarket notification filed by S. Cordero Co. with the FDA for The S. Cordero Stylus.
Device ID | K863808 |
510k Number | K863808 |
Device Name: | THE S. CORDERO STYLUS |
Classification | Handle, Scalpel |
Applicant | S. CORDERO CO. 2DA CERRADA DE CAMELIA NO. 30 COL. FLORIDA Mexico City Cp 01030, MX |
Contact | Sergio S Cordero |
Correspondent | Sergio S Cordero S. CORDERO CO. 2DA CERRADA DE CAMELIA NO. 30 COL. FLORIDA Mexico City Cp 01030, MX |
Product Code | GDZ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-30 |
Decision Date | 1986-10-14 |