Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polypropylene
More FDA Info for this Device |
510(K) Number |
K230746 |
Device Name |
Suture, Nonabsorbable, Synthetic, Polypropylene |
Applicant |
Shandong Haidike Medical Products Co.,Ltd.
Tianfu Road, Dongcheng District, Shan County,
Heze 274300 CN
Other 510(k) Applications for this Company
|
Contact |
Yan Wang
Other 510(k) Applications for this Contact |
Regulation Number |
878.5010
More FDA Info for this Regulation Number |
Classification Product Code |
GAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
03/17/2023 |
Decision Date |
09/14/2023 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
SU - General & Plastic Surgery |
Review Advisory Committee |
SU - General & Plastic Surgery |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|