Device Classification Name |
catheter, balloon, dilation of cervical canal
|
510(k) Number |
K160664 |
Device Name |
Aqueduct 100 Cervical Dilator |
Applicant |
GTIMD LLC |
6 COLUMBIA DRIVE |
AMHERST,
NH
03031
|
|
Applicant Contact |
RICHARD DEMELLO |
Correspondent |
GTIMD LLC |
6 COLUMBIA DRIVE |
AMHERST,
NH
03031
|
|
Correspondent Contact |
RICHARD DEMELLO |
Regulation Number | 884.4260
|
Classification Product Code |
|
Date Received | 03/09/2016 |
Decision Date | 08/01/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|