The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Dynacord Suture.
| Device ID | K181182 |
| 510k Number | K181182 |
| Device Name: | DYNACORD Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Medos International SARL Chemin-Blanc 38, Case Postale Le Locle, CH Ch 2400 |
| Contact | Tatyana Korsunsky |
| Correspondent | Tatyana Korsunsky DePuy Mitek, A Johnson And Johnson Company 325 Paramount Drive Raynham, MA 02767 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-03 |
| Decision Date | 2018-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886705030054 | K181182 | 000 |
| 20886705030047 | K181182 | 000 |
| 20886705030030 | K181182 | 000 |
| 20886705030023 | K181182 | 000 |
| 20886705030016 | K181182 | 000 |
| 20886705030009 | K181182 | 000 |
| 20886705029997 | K181182 | 000 |