The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Kooliner Ii.
| Device ID | K935261 |
| 510k Number | K935261 |
| Device Name: | KOOLINER II |
| 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 | 1993-11-03 |
| Decision Date | 1994-01-26 |