The following data is part of a premarket notification filed by Glustitch, Inc. with the FDA for Glustitch Twist Tissue Adhesive.
| Device ID | K150032 |
| 510k Number | K150032 |
| Device Name: | GluStitch Twist Tissue Adhesive |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | GLUSTITCH, INC. #307-7188 PROGRESS WAY Delta, CA V4g 1m6 |
| Contact | Don Blacklock |
| Correspondent | Tim Robinson REGULATORY AND CLINICAL RESEARCH INSTITUTE, INC. 5353 WAYZATA BLVD SUITE 505 Minneapolis, MN 55416 |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-08 |
| Decision Date | 2016-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B439013 | K150032 | 000 |
| D795G000151 | K150032 | 000 |
| D795122 | K150032 | 000 |
| D795112 | K150032 | 000 |
| D7950000131 | K150032 | 000 |