Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K090071 |
Device Name |
ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS |
Applicant |
ROSTAM LTD. |
30 NECK ROAD |
OLD LYME,
CT
06371
|
|
Applicant Contact |
ROBERT J STAAB |
Correspondent |
ROSTAM LTD. |
30 NECK ROAD |
OLD LYME,
CT
06371
|
|
Correspondent Contact |
ROBERT J STAAB |
Regulation Number | 884.5470
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/12/2009 |
Decision Date | 05/28/2009 |
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
|
|
|