The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Reline.
Device ID | K982695 |
510k Number | K982695 |
Device Name: | GC RELINE |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
Contact | Terry L Joritz |
Correspondent | Terry L Joritz GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-03 |
Decision Date | 1998-10-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10386040007078 | K982695 | 000 |
10386040003766 | K982695 | 000 |
10386040000871 | K982695 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GC RELINE 75854069 2479267 Live/Registered |
TRADEMARK HOLDINGS OF ILLINOIS LLC 1999-11-19 |