Device Classification Name |
Colposcope (And Colpomicroscope)
|
510(k) Number |
K932782 |
Device Name |
HM-0660 |
Applicant |
HILL-MED, INC. |
7217 N.W. 46TH ST. |
MIAMI,
FL
33166
|
|
Applicant Contact |
ERNESTO ACKERMAN |
Correspondent |
HILL-MED, INC. |
7217 N.W. 46TH ST. |
MIAMI,
FL
33166
|
|
Correspondent Contact |
ERNESTO ACKERMAN |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 06/09/1993 |
Decision Date | 03/23/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|