The following data is part of a premarket notification filed by Shandong Haidike Medical Product Co., Ltd. with the FDA for Non Absorbable Surgical Nylon Suture.
| Device ID | K212603 |
| 510k Number | K212603 |
| Device Name: | Non Absorbable Surgical Nylon Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | Shandong Haidike Medical Product Co., Ltd. Tianfu Road, Dongcheng District, Shan County Heze, CN 274300 |
| Contact | Lili Xu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-17 |
| Decision Date | 2021-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971642807002 | K212603 | 000 |
| 06971642807118 | K212603 | 000 |
| 06971642807125 | K212603 | 000 |
| 06971642807132 | K212603 | 000 |
| 06971642807149 | K212603 | 000 |
| 06971642807156 | K212603 | 000 |
| 06971642807163 | K212603 | 000 |
| 06971642807170 | K212603 | 000 |
| 06971642807187 | K212603 | 000 |
| 06971642807101 | K212603 | 000 |
| 06971642807095 | K212603 | 000 |
| 06971642807019 | K212603 | 000 |
| 06971642807026 | K212603 | 000 |
| 06971642807033 | K212603 | 000 |
| 06971642807040 | K212603 | 000 |
| 06971642807057 | K212603 | 000 |
| 06971642807064 | K212603 | 000 |
| 06971642807071 | K212603 | 000 |
| 06971642807088 | K212603 | 000 |
| 06971642807194 | K212603 | 000 |
| 06971642809600 | K212603 | 000 |
| 06971642809617 | K212603 | 000 |
| 06971642809723 | K212603 | 000 |
| 06971642809730 | K212603 | 000 |
| 06971642809747 | K212603 | 000 |
| 06971642809754 | K212603 | 000 |
| 06971642809761 | K212603 | 000 |
| 06971642809778 | K212603 | 000 |
| 06971642809785 | K212603 | 000 |
| 06971642809792 | K212603 | 000 |
| 06971642809716 | K212603 | 000 |
| 06971642809709 | K212603 | 000 |
| 06971642809624 | K212603 | 000 |
| 06971642809631 | K212603 | 000 |
| 06971642809648 | K212603 | 000 |
| 06971642809655 | K212603 | 000 |
| 06971642809662 | K212603 | 000 |
| 06971642809679 | K212603 | 000 |
| 06971642809686 | K212603 | 000 |
| 06971642809693 | K212603 | 000 |
| 06971642809808 | K212603 | 000 |