Device Classification Name |
Suture, Surgical, Absorbable, Polydioxanone
More FDA Info for this Device |
510(K) Number |
K190264 |
Device Name |
Suture, Surgical, Absorbable, Polydioxanone |
Applicant |
MEDITIME Co., Ltd
#605 Medical Device Complex, 200, Gieupdosi-ro,
Jijeong-Myeon
Won Ju 90010 KR
Other 510(k) Applications for this Company
|
Contact |
Yong Baik Kim
Other 510(k) Applications for this Contact |
Regulation Number |
878.4840
More FDA Info for this Regulation Number |
Classification Product Code |
NEW
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
02/08/2019 |
Decision Date |
08/15/2019 |
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 |
|