| Device Classification Name |
Pad, Menstrual, Unscented
|
| 510(k) Number |
K940329 |
| Device Name |
NATRACARE MENSTRUAL PADS |
| Applicant |
| Natracare, LLC |
| 191 University Blvd., Suite 294 |
|
Denver,
CO
80206
|
|
| Applicant Contact |
SUSAN CARSKADON |
| Correspondent |
| Natracare, LLC |
| 191 University Blvd., Suite 294 |
|
Denver,
CO
80206
|
|
| Correspondent Contact |
SUSAN CARSKADON |
| Regulation Number | 884.5435 |
| Classification Product Code |
|
| Date Received | 01/24/1994 |
| Decision Date | 04/13/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|