The following data is part of a premarket notification filed by Sm Eng Co., Ltd with the FDA for Crylrex.
| Device ID | K161629 |
| 510k Number | K161629 |
| Device Name: | CRYLREX |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | SM ENG CO., LTD 46, NAKDONG-DAERO 1302BEON-GIL Sasang-gu, KR |
| Contact | Soon-gu Lee |
| Correspondent | Sanglok Lee WISE COMPANY INC. #306, 3 DAERIM-RO 27GA-GIL Yeongdeungpo-gu, KR 07413 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-13 |
| Decision Date | 2017-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814639023920 | K161629 | 000 |
| 20814639023781 | K161629 | 000 |
| 20814639023798 | K161629 | 000 |
| 20814639023804 | K161629 | 000 |
| 10814639023876 | K161629 | 000 |
| 10814639023883 | K161629 | 000 |
| 10814639023890 | K161629 | 000 |
| 10814639023906 | K161629 | 000 |
| 10814639023913 | K161629 | 000 |
| 20814639023767 | K161629 | 000 |