Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K200392 |
Device Name |
REXSIN |
Applicant |
SM ENG CO., LTD |
46, Nakdong-daero 1302beon-gil |
Sasang-gu,
KR
46910
|
|
Applicant Contact |
Soon-Gu Lee |
Correspondent |
Wise Company Inc. |
#303, 142, Gasan digital 1-ro |
Geumcheon-gu,
KR
08507
|
|
Correspondent Contact |
Sanglok Lee |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 02/18/2020 |
Decision Date | 07/07/2020 |
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
|
|
|