Device Classification Name |
speculum, vaginal, nonmetal
|
510(k) Number |
K130046 |
Device Name |
CLEARSPEC SINGLE USE VAGINAL SPECULUM |
Applicant |
CLEARSPEC LLC |
603 GRANT STREET |
HERKIMER,
NY
13350
|
|
Applicant Contact |
IRA DUESLER |
Correspondent |
CLEARSPEC LLC |
603 GRANT STREET |
HERKIMER,
NY
13350
|
|
Correspondent Contact |
IRA DUESLER |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 01/08/2013 |
Decision Date | 08/06/2013 |
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
|
|
|