The following data is part of a premarket notification filed by Nantong Holycon Medical Devices Co., Ltd. with the FDA for Holycon Synthetic Absorbable Sutures.
| Device ID | K173043 |
| 510k Number | K173043 |
| Device Name: | Holycon Synthetic Absorbable Sutures |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | Nantong Holycon Medical Devices Co., Ltd. No.66, Zhongyang Road, Economic Technology Department Area Nantong, CN 226009 |
| Contact | Feng Lu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2017-12-14 |
| Summary: | summary |