Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyamide
|
510(k) Number |
K212603 |
Device Name |
Non Absorbable Surgical Nylon Suture |
Applicant |
Shandong Haidike Medical Product Co., Ltd. |
Tianfu Road, Dongcheng District, Shan County |
Heze,
CN
274300
|
|
Applicant Contact |
Lili Xu |
Correspondent |
Mid-Link Consulting Co., Ltd |
P.O. Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 878.5020
|
Classification Product Code |
|
Date Received | 08/17/2021 |
Decision Date | 12/22/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|