The following data is part of a premarket notification filed by Glustitch, Inc. with the FDA for Glusite, Model Glu002.
| Device ID | K013446 |
| 510k Number | K013446 |
| Device Name: | GLUSITE, MODEL GLU002 |
| Classification | Cement, Dental |
| Applicant | GLUSTITCH, INC. #307 7188 PROGRESS WAY Delta, B.c., CA V4g 1m6 |
| Contact | Don Blacklock |
| Correspondent | Don Blacklock GLUSTITCH, INC. #307 7188 PROGRESS WAY Delta, B.c., CA V4g 1m6 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-17 |
| Decision Date | 2001-12-20 |
| Summary: | summary |