Device Classification Name |
colposcope (and colpomicroscope)
|
510(k) Number |
K182764 |
Device Name |
Biop Digital Colposcope |
Applicant |
Biop Medical Ltd. |
10 O'haliav Street |
Ramat-Gan,
IL
5252263
|
|
Applicant Contact |
Ilan Landesman |
Correspondent |
Hogan Lovells US LLP |
1735 Market Street |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice Hogan |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 09/28/2018 |
Decision Date | 11/27/2018 |
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
|
|
|