Device Classification Name |
hemostatic wound dressing without thrombin or other biologics
|
510(k) Number |
K160679 |
Device Name |
WoundClot9 |
Applicant |
CORE SCIENTIFIC CREATION LTD. |
YOHANAN HASANDLAR 4 ST. |
POB 2270, 4464102 ISRAEL |
Kfar Saba,
IL
4464102
|
|
Applicant Contact |
YUVAL YASKIL |
Correspondent |
GSAP LTD. |
POB 3, SHAVE-ZION,
IL
22806
|
|
Correspondent Contact |
Sigalit Ariely-Portnoy |
Classification Product Code |
|
Date Received | 03/10/2016 |
Decision Date | 08/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|