Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K203241 |
Device Name |
OmniGuide BeamPath OTO-U Fiber |
Applicant |
OmniGuide, Inc. |
4 Maguire Road |
Lexington,
MA
02421
|
|
Applicant Contact |
David Johnson |
Correspondent |
OmniGuide, Inc. |
4 Maguire Road |
Lexington,
MA
02421
|
|
Correspondent Contact |
David Johnson |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 11/03/2020 |
Decision Date | 01/14/2021 |
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
|