Device Classification Name |
speculum, vaginal, nonmetal
|
510(k) Number |
K052420 |
Device Name |
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM |
Applicant |
GYNOVA, LLC |
698 MIDDLE TNPK E |
MANCHESTER,
CT
06040
|
|
Applicant Contact |
DON GUINAN |
Correspondent |
GYNOVA, LLC |
698 MIDDLE TNPK E |
MANCHESTER,
CT
06040
|
|
Correspondent Contact |
DON GUINAN |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 09/02/2005 |
Decision Date | 04/06/2006 |
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
|
|
|