The following data is part of a premarket notification filed by Kono Seisakusho Co., Ltd. with the FDA for Crownjun Nylon Suture.
| Device ID | K192420 |
| 510k Number | K192420 |
| Device Name: | Crownjun Nylon Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | Kono Seisakusho Co., Ltd. 3-43-16, Hongo Bunkyo-ku, JP 130-0033 |
| Contact | Hiroyuki Arai |
| Correspondent | Akiko Dohi Ken Block Consulting 800 East Campbell Drive, Suite 202 Richardson, TX 75081 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2020-05-29 |