The following data is part of a premarket notification filed by Msi with the FDA for Duramesh Mesh Suture.
| Device ID | K211178 |
| 510k Number | K211178 |
| Device Name: | DURAMESH Mesh Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | MSi One Magnificent Mile 980 N. Lake Shore Drive, Suite 1400 Chicago, IL 60611 |
| Contact | Greg Dumanian |
| Correspondent | Greg Dumanian MSi One Magnificent Mile 980 N. Lake Shore Drive, Suite 1400 Chicago, IL 60611 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-20 |
| Decision Date | 2022-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850008298131 | K211178 | 000 |
| 10850008298124 | K211178 | 000 |
| 10850008298117 | K211178 | 000 |
| 10850008298100 | K211178 | 000 |
| 10850008298094 | K211178 | 000 |
| 00850008298080 | K211178 | 000 |
| 00850008298073 | K211178 | 000 |