Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K140378 |
Device Name |
FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT |
Applicant |
OMNIGUIDE, INC. |
ONE KENDALL SQUARE |
SUITE B1301 |
CAMBRIDGE,
MA
02139
|
|
Applicant Contact |
NICOLE RASMUSSEN |
Correspondent |
OMNIGUIDE, INC. |
ONE KENDALL SQUARE |
SUITE B1301 |
CAMBRIDGE,
MA
02139
|
|
Correspondent Contact |
NICOLE RASMUSSEN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/14/2014 |
Decision Date | 09/25/2014 |
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
|