Device Classification Name |
Staple, Implantable
|
510(k) Number |
K162252 |
Device Name |
FasTouch Fixation System |
Applicant |
VIA SURGICAL LTD. |
MITZPE KINERET STREET 22/1 |
MOSHAV AMIRIM,
IL
20115
|
|
Applicant Contact |
OFEK LEVIN |
Correspondent |
NORTHSTAR BIOMEDICAL ASSOCIATES |
93 BENEFIT STREET |
PROVIDENCE,
RI
02904
|
|
Correspondent Contact |
LEO BASTA |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 08/10/2016 |
Decision Date | 11/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|