Device Classification Name |
tampon, menstrual, unscented
|
510(k) Number |
K122603 |
Device Name |
ONTEX AND OTHER PROPRIETARY NAMES |
Applicant |
ONTEX BVBA |
30 NECK ROAD |
OLD LYME,
CT
06371
|
|
Applicant Contact |
ROBERT J STAAB |
Correspondent |
ONTEX BVBA |
30 NECK ROAD |
OLD LYME,
CT
06371
|
|
Correspondent Contact |
ROBERT J STAAB |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 08/27/2012 |
Decision Date | 12/19/2012 |
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
|
|
|