Device Classification Name |
Endoscopic Guidewire, Gastroenterology-Urology
|
510(k) Number |
K133076 |
Device Name |
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE |
Applicant |
NEOMETRICS, INC. |
2605 FERNBROOK LANE N. |
SUITE J |
PLYMOUTH,
MN
55447
|
|
Applicant Contact |
DAVID LIEBL |
Correspondent |
NEOMETRICS, INC. |
2605 FERNBROOK LANE N. |
SUITE J |
PLYMOUTH,
MN
55447
|
|
Correspondent Contact |
DAVID LIEBL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/30/2013 |
Decision Date | 02/20/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|