Device Classification Name |
light, surgical, fiberoptic
|
510(k) Number |
K200874 |
Device Name |
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End |
Applicant |
Innovasis, Inc. |
614 East 3900 South |
Salt Lake City,
UT
84107
|
|
Applicant Contact |
Marshall McCarty |
Correspondent |
Innovasis, Inc. |
614 East 3900 South |
Salt Lake City,
UT
84107
|
|
Correspondent Contact |
Marshall McCarty |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 04/01/2020 |
Decision Date | 06/30/2020 |
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
|
|
|