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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14946585249225 | K192420 | 000 |
| 14946585357494 | K192420 | 000 |
| 14946585346436 | K192420 | 000 |
| 04946585348464 | K192420 | 000 |
| 04946585349676 | K192420 | 000 |
| 14946585349680 | K192420 | 000 |
| 14946585025102 | K192420 | 000 |
| 14946585025119 | K192420 | 000 |
| 14946585275002 | K192420 | 000 |
| 14946585275019 | K192420 | 000 |
| 04946585284069 | K192420 | 000 |
| 14946585285452 | K192420 | 000 |
| 14946585260664 | K192420 | 000 |
| 14946585261135 | K192420 | 000 |
| 04946585336409 | K192420 | 000 |
| 14946585233972 | K192420 | 000 |
| 14946585295581 | K192420 | 000 |
| 14946585228077 | K192420 | 000 |
| 04946585350139 | K192420 | 000 |