Device Classification Name |
clamp, circumcision
|
510(k) Number |
K151095 |
Device Name |
Circumplast Circumcision Device |
Applicant |
Novadien Healthcare |
PO Box 7070 |
Mount Lewis,
AU
NSW 2190
|
|
Applicant Contact |
Milad Melhem |
Correspondent |
Emergo Group |
816 Congress Avenue |
Suite 1400 |
Austin,
TX
78701
|
|
Correspondent Contact |
Diane Sudduth |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 04/23/2015 |
Decision Date | 09/18/2015 |
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
|
|
|