Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K160564 |
Device Name |
TroClose1200 |
Applicant |
GORDIAN SURGICAL LTD. |
17TH TCHELET ST. |
KARMIEL,
IL
2161401
|
|
Applicant Contact |
ZVI PEER |
Correspondent |
DR. SUSAN ALPERT |
200 PARK AVENUE, UNIT 111 |
MINNEAPOLIS,
MN
55415
|
|
Correspondent Contact |
SUSAN ALPERT |
Regulation Number | 878.4493
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/29/2016 |
Decision Date | 11/17/2016 |
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
|
Recalls |
CDRH Recalls
|
|
|