Device Classification Name |
Tenaculum, Uterine
|
510(k) Number |
K062563 |
Device Name |
FEMTEN CERVICAL TENACULUM |
Applicant |
FEM SUITE, L.L.C. |
1530 HOLCOMB STREET |
PORT TOWNSEND,
WA
98368
|
|
Applicant Contact |
CARL YOUNGMANN |
Correspondent |
FEM SUITE, L.L.C. |
1530 HOLCOMB STREET |
PORT TOWNSEND,
WA
98368
|
|
Correspondent Contact |
CARL YOUNGMANN |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 08/31/2006 |
Decision Date | 05/18/2007 |
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
|
|
|