Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K192891 |
Device Name |
Laparoscope Lens Shield Device (LENS) |
Applicant |
Medeon Biodesign, Inc |
7F, 116 Hougang St., |
Taipei,
TW
11170
|
|
Applicant Contact |
Tsung-Yu Hsieh |
Correspondent |
Medeon Biodesign, Inc |
7F, 116 Hougang St., |
Taipei,
TW
11170
|
|
Correspondent Contact |
Tsung-Yu Hsieh |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/10/2019 |
Decision Date | 11/07/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|