Device Classification Name |
Clip, Implantable
|
510(k) Number |
K093661 |
Device Name |
COLONRING |
Applicant |
NITI SURGICAL SOLUTIONS LTD |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN KAHAN |
Correspondent |
NITI SURGICAL SOLUTIONS LTD |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN KAHAN |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 11/25/2009 |
Decision Date | 02/10/2011 |
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
|
|
|