The following data is part of a premarket notification filed by Glustitch, Inc. with the FDA for Gluseal 90, Model Glu9010.
| Device ID | K083752 |
| 510k Number | K083752 |
| Device Name: | GLUSEAL 90, MODEL GLU9010 |
| Classification | Bandage, Liquid |
| 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 | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-17 |
| Decision Date | 2009-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B439033 | K083752 | 000 |
| B439023 | K083752 | 000 |
| D795220 | K083752 | 000 |
| D795143 | K083752 | 000 |
| D795130 | K083752 | 000 |