Device Classification Name |
Cutter, Surgical
|
510(k) Number |
K112400 |
Device Name |
SMARTSHEARS |
Applicant |
NUSCIENCE CONSULTING AND MANAGEMENT GROUP, LLC |
P.O. BOX 8507 |
FLEMING ISLAND,
FL
32006
|
|
Applicant Contact |
NIKOLE GOLDSMITH |
Correspondent |
NUSCIENCE CONSULTING AND MANAGEMENT GROUP, LLC |
P.O. BOX 8507 |
FLEMING ISLAND,
FL
32006
|
|
Correspondent Contact |
NIKOLE GOLDSMITH |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 08/19/2011 |
Decision Date | 09/12/2011 |
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
|
|
|