The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for G-coat.
| Device ID | K052462 |
| 510k Number | K052462 |
| Device Name: | G-COAT |
| Classification | Coating, Filling Material, Resin |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry L Joritz-lyons |
| Correspondent | Terry L Joritz-lyons GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-08 |
| Decision Date | 2005-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14548161293846 | K052462 | 000 |