The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Tescera Glazing Resin, Model T-1804, Biscover Xt, Model G-93220p.
Device ID | K024046 |
510k Number | K024046 |
Device Name: | TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P |
Classification | Coating, Filling Material, Resin |
Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
Contact | Stephen Smith |
Correspondent | Stephen Smith BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
Product Code | EBD |
CFR Regulation Number | 872.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-06 |
Decision Date | 2003-02-06 |
Summary: | summary |