Device Classification Name |
colposcope (and colpomicroscope)
|
510(k) Number |
K160380 |
Device Name |
LT-300 HD |
Applicant |
Lutech Industries, Inc. |
105 Remington Blvd., Suite C |
Ronkonkoma,
NY
11779
|
|
Applicant Contact |
Ronald Vachula |
Correspondent |
LEE & XIAO |
2600 MISSION ST, STE100 |
SAN MARINO,
CA
91108
|
|
Correspondent Contact |
JIMMY WU |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 02/10/2016 |
Decision Date | 05/13/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|