| Device Classification Name |
tampon, menstrual, unscented |
|||
|---|---|---|---|---|
| 510(k) Number | K023789 | |||
| Device Name | O.B. TAMPONS | |||
| Original Applicant |
|
|||
| Original Contact | diana l.b. uhl | |||
| Regulation Number | 884.5470 | |||
| Classification Product Code |
|
|||
| Date Received | 11/13/2002 | |||
| Decision Date | 12/06/2002 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Obstetrics/Gynecology |
|||
| 510k Review Panel |
Obstetrics/Gynecology |
|||
| summary |
summary |
|||
| Type | Special | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |