The following data is part of a premarket notification filed by Samyang Holdings Corp., Ltd. with the FDA for Monofix Pgcl, Knotless Wound Closure Device.
| Device ID | K212810 |
| 510k Number | K212810 |
| Device Name: | MONOFIX PGCL, Knotless Wound Closure Device |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | Samyang Holdings Corp., Ltd. 55, Munpyeongseo-ro, 18beon-gil Daedeok-gu, KR 34302 |
| Contact | Ahram Kim |
| Correspondent | Sanglok Lee Wise Company Inc. #507,#508 166, Gasan Digital 2-ro Geumcheon-gu, KR 08503 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-03 |
| Decision Date | 2022-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809766326483 | K212810 | 000 |
| 08809766324885 | K212810 | 000 |
| 08809766324861 | K212810 | 000 |
| 08809766324847 | K212810 | 000 |
| 08809766324809 | K212810 | 000 |
| 08809766324762 | K212810 | 000 |
| 08809766324748 | K212810 | 000 |
| 08809766324724 | K212810 | 000 |
| 08809766324700 | K212810 | 000 |
| 08809766324687 | K212810 | 000 |
| 08809766324663 | K212810 | 000 |
| 08809766324601 | K212810 | 000 |
| 08809766324588 | K212810 | 000 |
| 08809766324564 | K212810 | 000 |
| 08809766324908 | K212810 | 000 |
| 08809766325882 | K212810 | 000 |
| 08809766326469 | K212810 | 000 |
| 08809766326445 | K212810 | 000 |
| 08809766326421 | K212810 | 000 |
| 08809766326407 | K212810 | 000 |
| 08809766326353 | K212810 | 000 |
| 08809766326322 | K212810 | 000 |
| 08809766326308 | K212810 | 000 |
| 08809766326186 | K212810 | 000 |
| 08809766326100 | K212810 | 000 |
| 08809766326087 | K212810 | 000 |
| 08809766326063 | K212810 | 000 |
| 08809766326049 | K212810 | 000 |
| 08809766325905 | K212810 | 000 |
| 08809766324540 | K212810 | 000 |