The following data is part of a premarket notification filed by Summit Medical, Inc. with the FDA for Minne Ties Mmf Suture System.
| Device ID | K162046 |
| 510k Number | K162046 |
| Device Name: | MINNE TIES MMF Suture System |
| Classification | Lock, Wire, And Ligature, Intraoral |
| Applicant | SUMMIT MEDICAL, INC. 815 NORTHWEST PKWY, STE 100 St. Paul, MN 55121 |
| Contact | Nicole Dove |
| Correspondent | Nicole Dove SUMMIT MEDICAL, INC. 815 NORTHWEST PKWY, STE 100 St. Paul, MN 55121 |
| Product Code | DYX |
| CFR Regulation Number | 872.4600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-25 |
| Decision Date | 2017-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385640041751 | K162046 | 000 |
| 00850043178019 | K162046 | 000 |
| 00850043178026 | K162046 | 000 |
| 00860000906005 | K162046 | 000 |
| 00860000906012 | K162046 | 000 |
| 00860000906029 | K162046 | 000 |
| 00860000906036 | K162046 | 000 |
| 00385640042383 | K162046 | 000 |
| 00385640042406 | K162046 | 000 |
| 00385640042420 | K162046 | 000 |
| 00385640000642 | K162046 | 000 |
| 00385640028165 | K162046 | 000 |
| 00385640028172 | K162046 | 000 |
| 00385640028189 | K162046 | 000 |
| 00850043178002 | K162046 | 000 |