Device Classification Name |
Speculum, Vaginal, Nonmetal
|
510(k) Number |
K072942 |
Device Name |
MEDLINE DISPOSABLE VAGINAL SPECULUM |
Applicant |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Applicant Contact |
MATT CLAUSEN |
Correspondent |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Correspondent Contact |
MATT CLAUSEN |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 10/17/2007 |
Decision Date | 02/08/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|